FENTANYL
Report
- Report Number
- 2010441-2025-00007
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- January 1, 2025
- Report Date
- October 13, 2025
- Product Code
- QIX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MFR REPORT #: US-ALVOGEN-(B)(4) / 2010441-2025-00007. #1: DEVICE MALFUNCTION V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF ): FROM 2025 TO - NOT SERIOUS - UNKNOWN #2: DEVICE ADHESION ISSUE V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF ): FROM 2025 TO - NOT SERIOUS - UNKNOWN #3: DEVICE DEFECTIVE V28.0 (PATIENT HAD GONE THROUGH 5 PATCHES, AFTER ONE DAY THEY FELL OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE): FROM 2025 TO - NOT SERIOUS - UNKNOWN. #4: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS V28.0 (PATIENT USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH): FROM TO - NOT SERIOUS - UNKNOWN. #5: NO ADVERSE EVENT V28.0 (NO ADVERSE EVENT): FROM TO - NOT SERIOUS - UNKNOWN. THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTRE (MICC) (REFERENCE NUMBER: 202502563) FROM UNITED STATES ON 15-AUG-2025. THIS CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (PT: DEVICE ADHESION ISSUE, PT: DEVICE DEFECTIVE AND PT: DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (PT: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (PT: NO ADVERSE EVENT) (CLINICAL TERM: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS; PROBLEM TERM: LOSS OF OR FAILURE TO BOND, IMPROPER OR INCORRECT PROCEDURE OR METHOD, DEFECTIVE DEVICE). PATIENT'S RELEVANT MEDICAL HISTORY, PAST DRUG HISTORY, AND FAMILY HISTORY WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED THE USE OF FENTANYL FOR PAIN. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING OTHER MANUFACTURER PATCHES FOR 18-19 YEARS AND NEVER HAD A PROBLEM. CONCURRENT CONDITION INCLUDED PAIN. CONCOMITANT AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE IN (B)(6) -2025 (APPROXIMATELY 4 WEEKS AGO), THE PATIENT STARTED TREATMENT WITH FENTANYL TRANSDERMAL PATCH 12MCG/HR FOR 72 HOURS (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) (BATCH/LOT NUMBER: 109352, EXPIRATION DATE: SEP-2027 AND DEVICE MANUFACTURE DATE: UNKNOWN) FOR PAIN. USAGE OF THE DEVICE WAS UNKNOWN, AND THE OPERATOR OF DEVICE WAS LAY USER/PATIENT. PATIENT GOT 2 BOXES OF 5 PATCHES IN EACH BOX AND SHE TRIED TO USE 5 PATCHES. THE PATCHES WERE TO BE KEPT ON FOR 72 HOURS AND THEN TAKE IT OFF AND PUT ANOTHER ONE ON. SHE HAD GONE THROUGH 5 PATCHES AND AFTER ONE DAY THEY HAD FALLEN OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE, AND THEY COULD BE VERY HARMFUL BECAUSE SHE DID NOT KNOW WHERE THEY WOULD FALL OFF. SHE STATED THAT THEY COULD STILL HAVE MEDICINE IN THEM AND IF SHE HAD PUT A NEW PATCH ON, AND STEPPED ON THE FALLEN PATCH WHICH COULD GIVE MORE FENTANYL IN FOOT AND WOULD ALREADY HAVE ANOTHER PATCH ON ARM, SO IT WAS NOT GOOD. SHE HAD GONE THROUGH 5 PATCHES AND AFTER THE FIRST DAY THEY HAD FALLEN OFF. SHE MENTIONED THAT SHE NORMALLY DID NOT USE COMPANY PATCHES, SHE USED ANOTHER MANUFACTURER WHICH SHE HAD BEEN USING FOR 18 YEARS BUT THEY WERE BACK ORDERED SO THE PHARMACY GAVE HER COMPANY PATCHES. SHE APPLIED THE PATCH ON ARMS, SHE SWITCHED ARMS. SHE NEVER CLEANED THE APPLICATION SITE WITH SOAP AND WATER OR SHAVED THE APPLICATION SITE. SHE DID NOT APPLY LOTION ON THE APPLICATION SITE AND USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH. SHE HAD BEEN DOING THIS FOR 18-19 YEARS. SHE WAS NOT EXCESSIVELY SWEATING AT THE APPLICATION SITE. THE PATCHES WERE STICKING WELL WHEN SHE FIRST APPLIED THEM BUT THEN SHE WAS SHOCKED THAT SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY AND APPLIED A SECOND PATCH. THE SAME THING HAPPENED, AND SHE WENT THROUGH 5 OF THEM. SHE WENT TO THE PHARMACY AND TOLD THEM. PATIENT STATED THAT SHE ALWAYS APPLIED PRESSURE. SHE FURTHER CONFIRMED THAT THE PATCH DID NOT STAY EVEN FOR A FULL DAY, IT WAS HALF A DAY. SHE NOTICED THAT THE EDGES WERE NOT STICKING FIRST AND THEN THE ENTIRE PATCH. THE LEFT AND RIGHT EDGES WERE COMING OFF AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF. SHE NEVER USED A TAPE. AFTER APPLYING THE PATCH SHE DID NOT PARTICIPATE IN SPORT OR WATER ACTIVITIES OR ACTIVITIES. PATCH WAS NOT EXPOSED TO EXCESSIVE FRICTION AND SHE WAS NOT DOING ANY WATER ACTIVITIES LIKE SWIMMING. THE TEMPERATURE IN PATIENT'S LOCATION WAS IN THE HIGH 70S, IT WAS SUMMERTIME. PATIENT AGREED TO RETAIN THE COMPLAINT SAMPLE WITH HER AND MAIL THE COMPLAINT PRODUCT FOR FURTHER INVESTIGATION. SHE ONLY HAD 5 PATCHES LEFT AS SHE THREW AWAY THE OTHER PATCHES. PATIENT AGREED TO SEND A FEW HIGH-RESOLUTION PICTURES OF THE COMPLAINT SAMPLE SHOWING THE PRODUCT INFORMATION, LOT NUMBER AND EXPIRATION DATE. PATIENT INFORMED THAT SHE WAS NOT LOOKING FOR A REPLACEMENT AS SHE WAS NOT GOING TO USE THESE PATCHES AGAIN. SHE JUST WANTED TO LET US KNOW THAT THE PATCHES WERE DEFECTIVE. ON 24-AUG-2025, PATIENT SHARED 4 PICTURES OF THE DEFECTIVE PATCHES, THAT FALL OFF FROM HER ARM AFTER 1 DAY OF USE. SHE DISCARDED THOSE PATCHES AND CONFIRMED THAT SHE DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER USING THESE PATCHES. FURTHER, SHE STATED THAT SHE HAD RETURNED TO USING THEIR ORIGINAL FENTANYL PATCHES FROM THE PREVIOUS VENDOR, WHICH HAD BEEN OUT OF STOCK. TYPE OF INVESTIGATION WAS NOT YET DETERMINED. RESULTS AND CONCLUSION WERE PENDING AS INVESTIGATION WAS NOT YET COMPLETED. BASED ON MEDICAL REVIEW, THE REPORTED EVENTS MET THE FDA'S MDR REPORTABILITY CRITERIA AS DEFINED UNDER 21 CFR PART 803 AND QUALIFIES FOR 30-DAY REPORTING. NO LABORATORY TESTS AND PROCEDURES WERE REPORTED. THE CASE IS CONSIDERED AS NON-SERIOUS (IMPACT TERM: NO HEALTH CONSEQUENCES OR IMPACT). THE ACTION TAKEN WITH FENTANYL (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE REPORTER'S ASSESSMENT OF THE CAUSAL RELATIONSHIP OF THE EVENTS WITH FENTANYL WAS PROVIDED AS POSSIBLE AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW-UP INFORMATION OF THIS CASE WAS RECEIVED FROM A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTRE (MICC) (REFERENCE NUMBER: 202502563) FROM UNITED STATES ON 24-AUG-2025. PRODUCT DETAIL (START DATE) AND EVENTS ONSET DATE WAS ADDED. DEVICE AVAILABLE FOR EVALUATION WAS UPDATED FROM YES TO NO SINCE PATIENT DISCARDED THE PATCHES. CONFIRMATION ON NO ADVERSE EVENT EXPERIENCED WAS RECEIVED. NARRATIVE WAS UPDATED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE. MDR COMMENT: ACCORDING TO THE MEDICAL ASSESSMENT, AN ELDERLY FEMALE PATIENT OF UNKNOWN AGE USING FENTANYL TRANSDERMAL PATCHES FOR PAIN REPORTED THAT THE PATCHES WERE VERY DEFECTIVE, AS THEY FELL OFF AND DID NOT STAY ON. AFTER ONE DAY, THE PATCH FELL OFF; SHE FOUND THE FIRST PATCH ON THE FLOOR AND THREW IT AWAY. SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF AND THAT THE PATCHES DID NOT STICK TO THE BACK OF HER ARM BEFORE THE ENTIRE PATCH CAME OFF (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE AND DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, AS PER PI THE SKIN SITE MUST BE CLEANED WITH CLEAR WATER ONLY AND NO ALCOHOL SHOULD BE USED BEFORE THE PATCH IS APPLIED) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). A FOLLOW WAS RECEIVED PROVIDING THE DETAILS THAT PATIENT SHARED 4 PICTURES OF THE DEFECTIVE PATCHES, THAT FELL OFF FROM HER ARM AFTER 1 DAY OF USE. SHE DISCARDED THOSE PATCHES AND CONFIRMED THAT SHE DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER USING THESE PATCHES. ADDITIONALLY, PRODUCT DETAIL (START DATE) AND EVENTS ONSET DATE DETAILS WERE ALSO RECEIVED. IT IS IMPORTANT TO EMPHASIZE THAT ALTHOUGH THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS, THE FALLEN PATCH POSES A RISK OF ACCIDENTAL EXPOSURE. THEREFORE, DESPITE NO ADVERSE OUTCOMES BUT DUE TO POTENTIAL SAFETY RISKS THE CASE QUALIFIES FOR A 30-DAY MDR REPORT TO THE FDA. SENDER COMMENT: THIS 30-DAY REPORTABLE CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE AND DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT WERE ASSESSED AS NON-SERIOUS AND LISTED. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT IS ASSESSED AS UNCLASSIFIED.
MFR REPORT #: (B)(4) / 2010441-2025-00007. #1: DEVICE MALFUNCTION V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF): FROM 2025 TO - NOT SERIOUS - UNKNOWN. #2: DEVICE ADHESION ISSUE V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF): FROM 2025 TO - NOT SERIOUS - UNKNOWN. #3: DEVICE DEFECTIVE V28.0 (PATIENT HAD GONE THROUGH 5 PATCHES, AFTER ONE DAY THEY FELL OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE): FROM 2025 TO - NOT SERIOUS - UNKNOWN. #4: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS V28.0 (PATIENT USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH): FROM TO - NOT SERIOUS - UNKNOWN. #5: NO ADVERSE EVENT V28.0 (NO ADVERSE EVENT): FROM TO - NOT SERIOUS - UNKNOWN. THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTRE (MICC) (REFERENCE NUMBER: (B)(4) FROM UNITED STATES ON 15-AUG-2025. THIS CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (PT: DEVICE ADHESION ISSUE, PT: DEVICE DEFECTIVE AND PT: DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (PT: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (PT: NO ADVERSE EVENT) (CLINICAL TERM: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS; PROBLEM TERM: LOSS OF OR FAILURE TO BOND, IMPROPER OR INCORRECT PROCEDURE OR METHOD, DEFECTIVE DEVICE). PATIENT'S RELEVANT MEDICAL HISTORY, PAST DRUG HISTORY, AND FAMILY HISTORY WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED THE USE OF FENTANYL FOR PAIN. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING OTHER MANUFACTURER PATCHES FOR 18-19 YEARS AND NEVER HAD A PROBLEM. CONCURRENT CONDITION INCLUDED PAIN. CONCOMITANT AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2025 (APPROXIMATELY 4 WEEKS AGO), THE PATIENT STARTED TREATMENT WITH FENTANYL TRANSDERMAL PATCH 12MCG/HR FOR 72 HOURS (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) (BATCH/LOT NUMBER: 109352, EXPIRATION DATE: SEP-2027 AND DEVICE MANUFACTURE DATE: 25-SEP-2024) FOR PAIN. USAGE OF THE DEVICE WAS UNKNOWN, AND THE OPERATOR OF DEVICE WAS LAY USER/PATIENT. PATIENT GOT 2 BOXES OF 5 PATCHES IN EACH BOX AND SHE TRIED TO USE 5 PATCHES. THE PATCHES WERE TO BE KEPT ON FOR 72 HOURS AND THEN TAKE IT OFF AND PUT ANOTHER ONE ON. SHE HAD GONE THROUGH 5 PATCHES AND AFTER ONE DAY THEY HAD FALLEN OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE, AND THEY COULD BE VERY HARMFUL BECAUSE SHE DID NOT KNOW WHERE THEY WOULD FALL OFF. SHE STATED THAT THEY COULD STILL HAVE MEDICINE IN THEM AND IF SHE HAD PUT A NEW PATCH ON, AND STEPPED ON THE FALLEN PATCH WHICH COULD GIVE MORE FENTANYL IN FOOT AND WOULD ALREADY HAVE ANOTHER PATCH ON ARM, SO IT WAS NOT GOOD. SHE HAD GONE THROUGH 5 PATCHES AND AFTER THE FIRST DAY THEY HAD FALLEN OFF. SHE MENTIONED THAT SHE NORMALLY DID NOT USE COMPANY PATCHES, SHE USED ANOTHER MANUFACTURER WHICH SHE HAD BEEN USING FOR 18 YEARS BUT THEY WERE BACK ORDERED SO THE PHARMACY GAVE HER COMPANY PATCHES. SHE APPLIED THE PATCH ON ARMS, SHE SWITCHED ARMS. SHE NEVER CLEANED THE APPLICATION SITE WITH SOAP AND WATER OR SHAVED THE APPLICATION SITE. SHE DID NOT APPLY LOTION ON THE APPLICATION SITE AND USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH. SHE HAD BEEN DOING THIS FOR 18-19 YEARS. SHE WAS NOT EXCESSIVELY SWEATING AT THE APPLICATION SITE. THE PATCHES WERE STICKING WELL WHEN SHE FIRST APPLIED THEM BUT THEN SHE WAS SHOCKED THAT SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY AND APPLIED A SECOND PATCH. THE SAME THING HAPPENED, AND SHE WENT THROUGH 5 OF THEM. SHE WENT TO THE PHARMACY AND TOLD THEM. PATIENT STATED THAT SHE ALWAYS APPLIED PRESSURE. SHE FURTHER CONFIRMED THAT THE PATCH DID NOT STAY EVEN FOR A FULL DAY, IT WAS HALF A DAY. SHE NOTICED THAT THE EDGES WERE NOT STICKING FIRST AND THEN THE ENTIRE PATCH. THE LEFT AND RIGHT EDGES WERE COMING OFF AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF. SHE NEVER USED A TAPE. AFTER APPLYING THE PATCH, SHE DID NOT PARTICIPATE IN SPORT OR WATER ACTIVITIES OR ACTIVITIES. PATCH WAS NOT EXPOSED TO EXCESSIVE FRICTION AND SHE WAS NOT DOING ANY WATER ACTIVITIES LIKE SWIMMING. THE TEMPERATURE IN PATIENT'S LOCATION WAS IN THE HIGH 70S, IT WAS SUMMERTIME. PATIENT AGREED TO RETAIN THE COMPLAINT SAMPLE WITH HER AND MAIL THE COMPLAINT PRODUCT FOR FURTHER INVESTIGATION. SHE ONLY HAD 5 PATCHES LEFT AS SHE THREW AWAY THE OTHER PATCHES. PATIENT AGREED TO SEND A FEW HIGH-RESOLUTION PICTURES OF THE COMPLAINT SAMPLE SHOWING THE PRODUCT INFORMATION, LOT NUMBER AND EXPIRATION DATE. PATIENT INFORMED THAT SHE WAS NOT LOOKING FOR A REPLACEMENT AS SHE WAS NOT GOING TO USE THESE PATCHES AGAIN. SHE JUST WANTED TO LET US KNOW THAT THE PATCHES WERE DEFECTIVE. ON (B)(6) 2025, PATIENT SHARED 4 PICTURES OF THE DEFECTIVE PATCHES, THAT FALL OFF FROM HER ARM AFTER 1 DAY OF USE. SHE DISCARDED THOSE PATCHES AND CONFIRMED THAT SHE DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER USING THESE PATCHES. FURTHER, SHE STATED THAT SHE HAD RETURNED TO USING THEIR ORIGINAL FENTANYL PATCHES FROM THE PREVIOUS VENDOR, WHICH HAD BEEN OUT OF STOCK. ON 01-OCT-2025, INVESTIGATION SUMMARY REPORT REVEALED THAT NO SAMPLE WAS RETURNED FOR INVESTIGATION. NO PROBABLE CAUSE COULD BE DETERMINED BASED ON THE COMPLETED QC TESTING AND BATCH RECORD REVIEW. PRODUCT WAS RELEASED PER SPECIFICATION. HANDLING OUTSIDE OF COMPANY'S CONTROL CANNOT BE RULED OUT ONCE THE PRODUCT LEFT THE MANUFACTURING OR PACKAGING SITE. QC TESTS RESULTS MET THE REQUIRED SPECIFICATIONS. BATCH RECORD REVIEW FOR THE REPORTED COMPLAINT WAS COMPLETED AND THERE WAS NO MANUFACTURING ISSUES NOTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE CAUSE FOR THE ALLEGED COMPLAINT. PER CERTIFICATE OF MANUFACTURE, THE BATCH OF THIS PRODUCT WAS MANUFACTURED, INCLUDING PACKAGING AND QUALITY CONTROL IN FULL COMPLIANCE WITH ALL APPLICABLE GMP REGULATIONS AND MET APPROVED ACCEPTANCE SPECIFICATIONS. BATCH PROCESSING, PACKAGING, AND ANALYSIS RECORDS WERE REVIEWED AND FOUND TO BE IN COMPLIANCE OF GMP. NO CORRECTIVE ACTION/PREVENTIVE ACTION WILL BE RAISED AT THIS TIME (METHOD TERM: TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER, ANALYSIS OF PRODUCTION RECORDS; RESULT TERM: NO DEVICE PROBLEM FOUND; CONCLUSION TERM: NO PROBLEM DETECTED). BASED ON MEDICAL REVIEW, THE REPORTED EVENTS MET THE FDA'S MDR REPORTABILITY CRITERIA AS DEFINED UNDER 21 CFR PART 803 AND QUALIFIES FOR 30-DAY REPORTING. NO LABORATORY TESTS AND PROCEDURES WERE REPORTED. THE CASE IS CONSIDERED AS NON-SERIOUS (IMPACT TERM: NO HEALTH CONSEQUENCES OR IMPACT). THE ACTION TAKEN WITH FENTANYL (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE REPORTER'S ASSESSMENT OF THE CAUSAL RELATIONSHIP OF THE EVENTS WITH FENTANYL WAS PROVIDED AS POSSIBLE AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW-UP INFORMATION OF THIS CASE WAS RECEIVED FROM A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTRE (MICC) (REFERENCE NUMBER: (B)(4) FROM UNITED STATES ON 24-AUG-2025. PRODUCT DETAIL (START DATE) AND EVENTS ONSET DATE WAS ADDED. DEVICE AVAILABLE FOR EVALUATION WAS UPDATED FROM YES TO NO SINCE PATIENT DISCARDED THE PATCHES. CONFIRMATION ON NO ADVERSE EVENT EXPERIENCED WAS RECEIVED. NARRATIVE WAS UPDATED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW UP INFORMATION OF THIS CASE WAS RECEIVED FROM PRODUCT QUALITY GROUP VIA EMAIL ON 01-OCT-2025. INVESTIGATION SUMMARY REPORT WAS ADDED. REFERENCE NUMBERS (B)(4) AND DEVICE RELATED DETAILS WERE ADDED. THE NARRATIVE WAS UPDATED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE. MDR COMMENT: ACCORDING TO THE MEDICAL ASSESSMENT, AN ELDERLY FEMALE PATIENT OF UNKNOWN AGE USING FENTANYL TRANSDERMAL PATCHES FOR PAIN REPORTED THAT THE PATCHES WERE VERY DEFECTIVE, AS THEY FELL OFF AND DID NOT STAY ON. AFTER ONE DAY, THE PATCH FELL OFF; SHE FOUND THE FIRST PATCH ON THE FLOOR AND THREW IT AWAY. SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF AND THAT THE PATCHES DID NOT STICK TO THE BACK OF HER ARM BEFORE THE ENTIRE PATCH CAME OFF (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, AS PER PI THE SKIN SITE MUST BE CLEANED WITH CLEAR WATER ONLY AND NO ALCOHOL SHOULD BE USED BEFORE THE PATCH IS APPLIED) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). A FOLLOW WAS RECEIVED PROVIDING THE DETAILS THAT PATIENT SHARED 4 PICTURES OF THE DEFECTIVE PATCHES, THAT FELL OFF FROM HER ARM AFTER 1 DAY OF USE. SHE DISCARDED THOSE PATCHES AND CONFIRMED THAT SHE DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER USING THESE PATCHES. ADDITIONALLY, PRODUCT DETAIL (START DATE) AND EVENTS ONSET DATE DETAILS WERE ALSO RECEIVED. INVESTIGATION SUMMARY REPORT REVEALED THAT NO SAMPLE WAS RETURNED SO NO PROBABLE CAUSE COULD BE DETERMINED, AND NO CORRECTIVE ACTION/PREVENTIVE ACTION WAS RAISED. ALTHOUGH THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS, THE FALLEN PATCH POSES A RISK OF ACCIDENTAL EXPOSURE, THEREFORE THIS CASE QUALIFIES FOR 30-DAY MDR REPORTING TO THE FDA. SENDER COMMENT: THIS PERIODICALLY REPORTABLE CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE AND DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT WERE ASSESSED AS NON-SERIOUS AND LISTED. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT IS ASSESSED AS UNCLASSIFIED.
MFR REPORT #: (B)(4). #1: DEVICE MALFUNCTION V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF): FROM TO - NOT SERIOUS - UNKNOWN #2: DEVICE ADHESION ISSUE V28.0 (PATIENT USED 5 PATCHES, AFTER ONE DAY THEY FELL OFF, SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, LEFT AND RIGHT EDGES WERE COMING OFF, DID NOT STICK, THEN THE ENTIRE PATCH CAME OFF): FROM TO - NOT SERIOUS - UNKNOWN #3: DEVICE DEFECTIVE V28.0 (PATIENT HAD GONE THROUGH 5 PATCHES, AFTER ONE DAY THEY FELL OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE): FROM TO - NOT SERIOUS - UNKNOWN. #4: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS V28.0 (PATIENT USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH): FROM TO - NOT SERIOUS - UNKNOWN. #5: NO ADVERSE EVENT V28.0 (NO ADVERSE EVENT): FROM TO - NOT SERIOUS - UNKNOWN. THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM CONSUMER OR OTHER NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTRE (MICC) (REFERENCE NUMBER: (B)(4) FROM UNITED STATES ON (B)(6) 2025. THIS CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (PT: DEVICE ADHESION ISSUE, PT: DEVICE DEFECTIVE AND PT: DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (PT: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (PT: NO ADVERSE EVENT) (CLINICAL TERM: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS; PROBLEM TERM: LOSS OF OR FAILURE TO BOND, IMPROPER OR INCORRECT PROCEDURE OR METHOD, DEFECTIVE DEVICE). PATIENT'S RELEVANT MEDICAL HISTORY, PAST DRUG HISTORY, AND FAMILY HISTORY WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED THE USE OF FENTANYL FOR PAIN. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING OTHER MANUFACTURER PATCHES FOR 18-19 YEARS AND NEVER HAD A PROBLEM. CONCURRENT CONDITION INCLUDED PAIN. CONCOMITANT AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FENTANYL TRANSDERMAL PATCH 12MCG/HR FOR 72 HOURS (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) (BATCH/LOT NUMBER: 109352, EXPIRATION DATE: UU-SEP-2027 AND DEVICE MANUFACTURE DATE: UNKNOWN) FOR PAIN. USAGE OF THE DEVICE WAS UNKNOWN AND THE OPERATOR OF DEVICE WAS LAY USER/PATIENT. PATIENT GOT 2 BOXES OF 5 PATCHES IN EACH BOX AND SHE TRIED TO USE 5 PATCHES. THE PATCHES WERE TO BE KEPT ON FOR 72 HOURS AND THEN TAKE IT OFF AND PUT ANOTHER ONE ON. SHE HAD GONE THROUGH 5 PATCHES AND AFTER ONE DAY THEY HAD FALLEN OFF, THEY DID NOT STAY ON SO SHE STATED THAT THEY WERE OBVIOUSLY VERY DEFECTIVE, AND THEY COULD BE VERY HARMFUL BECAUSE SHE DID NOT KNOW WHERE THEY WOULD FALL OFF. SHE STATED THAT THEY COULD STILL HAVE MEDICINE IN THEM AND IF SHE HAD PUT A NEW PATCH ON AND STEPPED ON THE FALLEN PATCH WHICH COULD GIVE MORE FENTANYL IN FOOT AND WOULD ALREADY HAVE ANOTHER PATCH ON ARM, SO IT WAS NOT GOOD. SHE HAD GONE THROUGH 5 PATCHES AND AFTER THE FIRST DAY THEY HAD FALLEN OFF. SHE MENTIONED THAT SHE NORMALLY DID NOT USE COMPANY PATCHES, SHE USED ANOTHER MANUFACTURER WHICH SHE HAD BEEN USING FOR 18 YEARS BUT THEY WERE BACK ORDERED SO THE PHARMACY GAVE HER COMPANY PATCHES. SHE APPLIED THE PATCH ON ARMS, SHE SWITCHED ARMS. SHE NEVER CLEANED THE APPLICATION SITE WITH SOAP AND WATER OR SHAVED THE APPLICATION SITE. SHE DID NOT APPLY LOTION ON THE APPLICATION SITE AND USED ALCOHOL RUB AND WAITED TILL IT DRIED THEN SHE APPLIED THE PATCH. SHE HAD BEEN DOING THIS FOR 18-19 YEARS. SHE WAS NOT EXCESSIVELY SWEATING AT THE APPLICATION SITE. THE PATCHES WERE STICKING WELL WHEN SHE FIRST APPLIED THEM BUT THEN SHE WAS SHOCKED THAT SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY AND APPLIED A SECOND PATCH. THE SAME THING HAPPENED, AND SHE WENT THROUGH 5 OF THEM. SHE WENT TO THE PHARMACY AND TOLD THEM. PATIENT STATED THAT SHE ALWAYS APPLIED PRESSURE. SHE FURTHER CONFIRMED THAT THE PATCH DID NOT STAY EVEN FOR A FULL DAY, IT WAS HALF A DAY. SHE NOTICED THAT THE EDGES WERE NOT STICKING FIRST AND THEN THE ENTIRE PATCH. THE LEFT AND RIGHT EDGES WERE COMING OFF AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF. SHE NEVER USED A TAPE. AFTER APPLYING THE PATCH, SHE DID NOT PARTICIPATE IN SPORT OR WATER ACTIVITIES OR ACTIVITIES. PATCH WAS NOT EXPOSED TO EXCESSIVE FRICTION AND SHE WAS NOT DOING ANY WATER ACTIVITIES LIKE SWIMMING. THE TEMPERATURE IN PATIENT'S LOCATION WAS IN THE HIGH 70S, IT WAS SUMMERTIME. PATIENT AGREED TO RETAIN THE COMPLAINT SAMPLE WITH HER AND MAIL THE COMPLAINT PRODUCT FOR FURTHER INVESTIGATION. SHE ONLY HAD 5 PATCHES LEFT AS SHE THREW AWAY THE OTHER PATCHES. PATIENT AGREED TO SEND A FEW HIGH-RESOLUTION PICTURES OF THE COMPLAINT SAMPLE SHOWING THE PRODUCT INFORMATION, LOT NUMBER AND EXPIRATION DATE. PATIENT INFORMED THAT SHE WAS NOT LOOKING FOR A REPLACEMENT AS SHE WAS NOT GOING TO USE THESE PATCHES AGAIN. SHE JUST WANTED TO LET US KNOW THAT THE PATCHES WERE DEFECTIVE. TYPE OF INVESTIGATION WAS NOT YET DETERMINED. RESULTS AND CONCLUSION WERE PENDING AS INVESTIGATION WAS NOT YET COMPLETED. BASED ON MEDICAL REVIEW, THE REPORTED EVENT DOES NOT MEET THE FDA'S MDR REPORTABILITY CRITERIA AS DEFINED UNDER 21 CFR PART 803. NO LABORATORY TESTS AND PROCEDURES WERE REPORTED. THE CASE IS CONSIDERED AS NON-SERIOUS (IMPACT TERM: NO HEALTH CONSEQUENCES OR IMPACT). THE ACTION TAKEN WITH FENTANYL (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE REPORTER'S ASSESSMENT OF THE CAUSAL RELATIONSHIP OF THE EVENTS WITH FENTANYL WAS PROVIDED AS POSSIBLE AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE. MDR COMMENT: ACCORDING TO THE MEDICAL ASSESSMENT, AN ELDERLY FEMALE PATIENT OF UNKNOWN AGE USING FENTANYL TRANSDERMAL PATCHES FOR PAIN REPORTED THAT THE PATCHES WERE VERY DEFECTIVE, AS THEY FELL OFF AND DID NOT STAY ON. AFTER ONE DAY, THE PATCH FELL OFF; SHE FOUND THE FIRST PATCH ON THE FLOOR AND THREW IT AWAY. SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF AND THAT THE PATCHES DID NOT STICK TO THE BACK OF HER ARM BEFORE THE ENTIRE PATCH CAME OFF. (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE AND DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, AS PER PI THE SKIN SITE MUST BE CLEANED WITH CLEAR WATER ONLY AND NO ALCOHOL SHOULD BE USED BEFORE THE PATCH IS APPLIED) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). IT IS IMPORTANT TO EMPHASIZE THAT ALTHOUGH THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS, THE FALLEN PATCH POSES A RISK OF ACCIDENTAL EXPOSURE. THEREFORE, DESPITE NO ADVERSE OUTCOMES BUT DUE TO POTENTIAL SAFETY RISKS THE CASE QUALIFIES FOR A 30-DAY MDR REPORT TO THE FDA. SENDER COMMENT: THIS 30-DAY REPORTABLE CASE CONCERNS AN ELDERLY FEMALE PATIENT OF AN UNKNOWN AGE WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR PAIN AND REPORTED THAT THE PATCHES WERE VERY DEFECTIVE AS PATCHES FELL OFF AND DID NOT STAY ON, AFTER ONE DAY THEY FELL OFF AND SHE FOUND THE FIRST PATCH ON THE FLOOR SO SHE THREW IT AWAY, SHE CONFIRMED THAT THE LEFT AND RIGHT EDGES WERE COMING OFF, AND THEY DID NOT STICK TO THE BACK OF HER ARM AND THEN THE ENTIRE PATCH CAME OFF (DEVICE ADHESION ISSUE, DEVICE DEFECTIVE AND DEVICE MALFUNCTION). SHE FURTHER REPORTED THAT SHE USED AN ALCOHOL RUB AND WAITED FOR IT TO DRY BEFORE APPLYING THE PATCH (WRONG TECHNIQUE IN PRODUCT USAGE PROCESS) AND EXPERIENCED NO ADVERSE EVENT (NO ADVERSE EVENT). THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT WERE ASSESSED AS NON-SERIOUS AND LISTED. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENTS OF DEVICE ADHESION ISSUE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND NO ADVERSE EVENT IS ASSESSED AS UNCLASSIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245155 | FENTANYL | SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED | QIX | 109352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |