FENTANYL
Report
- Report Number
- 2010441-2025-00006
- Event Type
- Injury
- Date Received
- August 8, 2025
- Date of Event
- February 1, 2025
- Report Date
- August 8, 2025
- Product Code
- QIX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- OTHER
Narratives
MANUFACTURER REPORT NUMBER: 2010441-2025-00006, WILL BE SUBMITTED AS A INITIAL 30-DAY REPORT WITH RECEIPT DATE (DAY 0): 11-JUL-2025 BY REMOVING MOST RECENT INFORMATION LOGS FROM THE CASE. THE INITIAL VERSION (5-DAY AND 15-DAY) OF THE CASE WAS RECEIVED ON 24-MAY-2025. THE FOLLOW UP VERSION 1 (NON-REPORTABLE) AND FOLLOW UP VERSION 2 (NON-REPORTABLE) WERE RECEIVED ON 09-JUN-2025 AND 13-JUN-2025, RESPECTIVELY. THE INITIAL VERSION WAS SUBMITTED ON 02-JUN-2025 AS AN E2B R2 XML FILE ALONG WITH MDR FORM IN PDF FILE FORMAT VIA THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) AS2. ON 11-JUL-2025, DEVICE EVALUATION REPORT WAS RECEIVED IN FOLLOW UP VERSION 3. AS THE PREVIOUS CASE VERSION WAS NOT SUBMITTED AS XML HL7 FILE, HENCE, THE INFORMATION RECEIVED ON 24-MAY-2025 AND 11-JUL-2025 WILL BE SUBMITTED AS AN INITIAL REPORT WITH THE RECEIPT DATE (DAY 0): 11-JUL-2025 AS A SINGLE REPORT.
MFR REPORT #: US-ALVOGEN-(B)(4) / 2010441-2025-00006. #1: UNRESPONSIVE TO STIMULI V28.0 (PATIENT WAS FOUND UNRESPONSIVE BY FAMILY AND ALMOST DIED): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #2: DRUG OVERDOSE V28.0 (PATIENT USED FAULTY PRODUCT AND WOUND UP HOSPITALIZED FOR AN OVERDOSE): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #3: DEVICE DEFECTIVE V28.0 (PATEINT USED FAULTY PRODUCT AND WOUND UP HOSPITALIZED FOR AN OVERDOSE): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #4: DEVICE MALFUNCTION V28.0 (PATEINT USED FAULTY PRODUCT AND WOUND UP HOSPITALIZED FOR AN OVERDOSE): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #5: MANUFACTURING ISSUE V28.0 (PATIENT HAD MORE PATCHES ON THAN HE/SHE SHOULD HAVE BECAUSE OF THE COMPANY'S MANUFACTURING ERRORS): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #6: RECALLED PRODUCT V28.0 (THE PATIENT FOUND THAT THE LOT WAS RECALLED AFTER THE OCCURRENCE OF THE EVENTS): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. #7: RECALLED PRODUCT ADMINISTERED V28.0 (THE PATIENT FOUND THAT THE LOT WAS RECALLED AFTER THE OCCURRENCE OF THE EVENTS): FROM (B)(6) 2025 TO - SERIOUS - UNKNOWN. THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A CONSUMER OR NON-HEALTH PROFESSIONAL (PATIENT) VIA MEDICAL INFORMATION CALL CENTER (MICC) (REFERENCE NUMBER: (B)(4)) FROM UNITED STATES ON 24-MAY-2025. THIS CASE CONCERNS A PATIENT OF UNKNOWN AGE AND GENDER WHO WAS USING FENTANYL PATCH FOR AN UNKNOWN INDICATION AND REPORTED THAT AFTER USING FAULTY PRODUCT (PT: DEVICE DEFECTIVE AND PT: DEVICE MALFUNCTION), THE PATIENT WOUND UP HOSPITALIZED FOR AN OVERDOSE (PT: OVERDOSE) AS THE PATIENT WAS FOUND UNRESPONSIVE BY FAMILY (PT: UNRESPONSIVE TO STIMULI). THE PATIENT FOUND THAT THE LOT WAS RECALLED (PT: RECALLED PRODUCT AND PT: RECALLED PRODUCT ADMINISTERED) AFTER THE OCCURRENCE OF THE EVENTS AND STATED THAT HE/SHE HAD MORE PATCHES ON THAN HE/SHE SHOULD HAVE BECAUSE OF THE COMPANY'S MANUFACTURING ERRORS (PT: MANUFACTURING ISSUE). (CLINICAL TERM: LOSS OF CONSCIOUSNESS; PROBLEM TERM: DEFECTIVE DEVICE, MANUFACTURING, PACKAGING OR SHIPPING PROBLEM). PATIENT'S RELEVANT MEDICAL HISTORY, PAST DRUG HISTORY AND FAMILY HISTORY WAS NOT REPORTED. CONCURRENT CONDITIONS, CONCOMITANT AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FENTANYL TRANSDERMAL PATCHES 25 MCG/HR (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) (BATCH/LOT NUMBER: 108319, EXPIRATION DATE: 30-APR-2027) FOR AN UNKNOWN INDICATION. THE PATIENT FOUND THAT THE LOT WAS RECALLED AFTER THE OCCURRENCE OF THE EVENTS. USAGE OF THE DEVICE WAS UNKNOWN, AND THE OPERATOR OF DEVICE WAS PATIENT. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2025, PATIENT WAS FOUND UNRESPONSIVE BY FAMILY AFTER THEY HAD TO CALL A WELLNESS CHECK ON PATIENT AND POLICE BROKE DOWN HIS/HER DOOR WHICH COSTED THE MONEY AND MAY LEAD TO AN EVICTION OR NON-RENEWAL OF THE LEASE WHICH WOULD LEAVE THE PATIENT HOMELESS. THE PATIENT WOUND UP HOSPITALIZED FOR AN OVERDOSE BECAUSE OF USING FAULTY PRODUCT AND HAD ALMOST DIED WHICH COSTED HIS/HER INSURANCE MONEY AND TRAUMATIZED THE PATIENT'S FAMILY AND THE PATIENT. ALSO, MENTIONED THAT PATIENT WAS TREATED POORLY AT THE HOSPITAL BECAUSE THEY ASSUMED THE PATIENT OVERDOSED HIMSELF/HERSELF ON PURPOSE WHICH WAS NOT THE CASE. PATIENT FURTHER MENTIONED THAT THE WHOLE EVENT WAS HORRIBLE AND TERRIFYING AS THE HE/SHE MIGHT LOSE THE APARTMENT AND BECOME HOMELESS. ON (B)(6) 2025, PATIENT STATED THAT HE/SHE GOT LUCKY THAT SOMEONE SHOWED UP TO SAVE HIM/HER. BUT PATIENT'S LIFE WAS NOW IN CHAOS BECAUSE OF THIS INCIDENT. PATIENT WAS PAYING FOR THE FOOT BEING BUSTED DOWN, HIS/HER LANDLORD WANTED TO EVICT HIM/HER. PATIENT HAD TO GIVE UP EMOTIONAL SUPPORT WHICH WAS CAT BECAUSE HE/SHE WAS TOO MESSED UP TO CARE FOR HER PROPERLY. THIS EVENT REALLY MESSED UP SO MUCH PROGRESS PATIENT HAD MADE. PATIENT COULD NOT EVEN DESCRIBE THE TRAUMA NOT JUST PATIENT, BUT ALL THE FAMILY EXPERIENCED. PATIENT ALSO STATED THAT HE/SHE HAD MORE PATCHES ON THAN HE/SHE SHOULD HAVE BECAUSE OF THE COMPANY'S MANUFACTURING ERRORS. ON (B)(6) 2025, INVESTIGATION SUMMARY REPORT REVEALED THAT NO SAMPLE WAS RETURNED DURING THE TIME OF COMPLAINT. AT THIS TIME, THERE IS NO AVAILABLE INFORMATION PROVIDED TO COMPANY. IF ADDITIONAL INFORMATION IS RECEIVED OR THE COMPLAINT SAMPLE IS AVAILABLE ON A LATER DATE, THE FILE IS REVIEWED TO DETERMINE IF FURTHER INVESTIGATION IS NEEDED. THE QC LAB TEST RESULTS OF THE RETAIN SAMPLES FOR THE LOT REFERENCED MET THE ACCEPTANCE SPECIFICATION. NOTHING WAS NOTED DURING QC TESTING OF RETAIN SAMPLES THAT ARE ATYPICAL OF NORMAL AND EXPECTED RESULTS. 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. BATCH 108319 WAS RECALLED AS PART OF DEV-2025-0004 FOLLOWING A COMPLAINT FOR OVERLAPPED PATCHES. THE COMPLAINT REPORT DID NOT MENTION ANY ABNORMAL PHYSICAL FEATURES ABOUT THE PATCH AND THE PATIENT COULD NOT BE CONTACTED FOR MORE INFORMATION. (METHOD TERM: TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER, DEVICE NOT RETURNED, RESULT TERM: NO DEVICE PROBLEM FOUND, CONCLUSION TERM: NO PROBLEM DETECTED). BASED ON MEDICAL REVIEW, THE REPORTED EVENTS MEET THE FDA'S MDR REPORTABILITY CRITERIA AS DEFINED UNDER 21 CFR PART 803 AND QUALIFIES FOR 30-DAY REPORTING. THE REMEDIAL ACTION WAS INITIATED AS RECALL. NO LABORATORY TESTS AND PROCEDURES WERE REPORTED. THE CASE IS CONSIDERED AS SERIOUS (OTHER MEDICALLY IMPORTANT CONDITION AND HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION) FOR THE EVENT LOSS OF CONSCIOUSNESS, AND SERIOUS (OTHER MEDICALLY IMPORTANT CONDITION) FOR EVENTS OVERDOSE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, MANUFACTURING ISSUE, RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED. (IMPACT CODE: OVERDOSE, SERIOUS INJURY/ILLNESS/IMPAIRMENT) THE ACTION TAKEN WITH FENTANYL (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED; APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) WAS UNKNOWN. 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 MEDICAL INFORMATION CALL CENTER (MICC) (REFERENCE NUMBER: (B)(4)) ON 09-JUN-2025. NO SIGNIFICANT INFORMATION WAS RECEIVED. NARRATIVE WAS UPDATED ACCORDINGLY. FOLLOW UP INFORMATION WAS RECEIVED FROM A CONSUMER OR NON-HEALTH PROFESSIONAL (PATIENT) VIA FDA (AER#(B)(4)) (MEDICAL INFORMATION CALL CENTER, MICC ID: (B)(4)) FROM UNITED STATES ON 13-JUN-2025. ADDITIONAL EVENTS (MANUFACTURING ISSUE, RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED), REPORTER DETAILS (ADDRESS), REFERENCE NUMBER ((B)(4)) AND PRODUCT DETAILS (NDC NUMBER) WERE ADDED. EXPIRATION DATE WAS UPDATED (FROM UU-APR-2027 TO 30-APR-2027). NARRATIVE WAS UPDATED ACCORDINGLY NO FURTHER INFORMATION IS AVAILABLE. FOLLOW UP INFORMATION OF THIS CASE WAS RECEIVED FROM PRODUCT QUALITY GROUP FROM UNITED STATES ON 11-JUL-2025. INVESTIGATION SUMMARY REPORT, REFERENCE NUMBERS ((B)(4)) AND DEVICE RELATED DETAILS WERE ADDED. NARRATIVE WAS UPDATED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE. THE INITIAL VERSION (5-DAY AND 15-DAY) OF THE CASE WAS RECEIVED ON 24-MAY-2025. THE FOLLOW UP VERSION 1 (NON-REPORTABLE) AND FOLLOW UP VERSION 2 (NON-REPORTABLE) WERE RECEIVED ON 09-JUN-2025 AND 13-JUN-2025, RESPECTIVELY. THE INITIAL VERSION WAS SUBMITTED ON 02-JUN-2025 AS AN E2B R2 XML FILE ALONG WITH MDR FORM IN PDF FILE FORMAT VIA THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) AS2. ON 11-JUL-2025, DEVICE EVALUATION REPORT WAS RECEIVED IN FOLLOW UP VERSION 3. AS THE PREVIOUS CASE VERSION WAS NOT SUBMITTED AS XML HL7 FILE, HENCE, THE INFORMATION RECEIVED ON 24-MAY-2025 AND 11-JUL-2025 WILL BE SUBMITTED AS AN INITIAL REPORT WITH THE RECEIPT DATE (DAY 0): 11-JUL-2025 AS A SINGLE REPORT. MDR COMMENT: ACCORDING TO THE MEDICAL ASSESSMENT, THE PATIENT, WHO WAS USING A FENTANYL PATCH (BATCH 108319) FOR AN UNKNOWN INDICATION, REPORTEDLY EXPERIENCED AN OVERDOSE FOLLOWING THE USE OF A FAULTY PRODUCT (DEVICE DEFECTIVE AND DEVICE MALFUNCTION). THE PATIENT WAS FOUND UNRESPONSIVE BY FAMILY MEMBERS (UNRESPONSIVE TO STIMULI) AND WAS SUBSEQUENTLY HOSPITALIZED. SINCE, THE DEFECTIVE PATCH LED TO SERIOUS ADVERSE EVENTS POSING AN IMPACT ON PUBLIC HEALTH HENCE THE BATH WAS RECALLED FROM THE MARKET AND WAS SUBMITTED AS A 5-DAY REPORT TO THE FDA. A FOLLOW-UP TO A PREVIOUSLY REPORTED 5-DAY REPORT WAS RECEIVED, HOWEVER, IN THE NOW RECEIVED FOLLOW UP INFORMATION THE PATIENT FOUND THAT THE LOT WAS RECALLED (RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED) AFTER THE OCCURRENCE OF THE EVENTS AND STATED THAT HE/SHE HAD MORE PATCHES ON THAN HE/SHE SHOULD HAVE BECAUSE OF THE COMPANY'S MANUFACTURING ERRORS (MANUFACTURING ISSUE). HENCE AS PER THE FOLLOW UP INFORMATION THE CASE NOW QUALIFIES FOR SUBMISSION IN 30-DAYS TO FDA. (AS PER GUIDANCE THE FOLLOW UP VERSION OF 5-DAY REPORTABLE CASES QUALIFIES FOR SUBMISSION IN 30-DAY.) A FOLLOW-UP TO A PREVIOUSLY REPORTED 30-DAY REPORT WAS RECEIVED. THE INVESTIGATION SUMMARY REPORT INDICATED THAT NO SAMPLE WAS RETURNED AT THE TIME OF THE COMPLAINT. CURRENTLY, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO THE COMPANY. A BATCH RECORD REVIEW FOR THE REPORTED COMPLAINT WAS COMPLETED, AND NO MANUFACTURING ISSUES WERE IDENTIFIED DURING THE PRODUCTION OF THE LOT THAT COULD HAVE CONTRIBUTED TO THE ALLEGED COMPLAINT. THE COMPLAINT REPORT DID NOT MENTION ANY ABNORMAL PHYSICAL CHARACTERISTICS OF THE PATCH, AND THE PATIENT COULD NOT BE CONTACTED FOR FURTHER DETAILS. THEREFORE, THE INFORMATION RECEIVED DOES NOT IMPACT THE PREVIOUS MEDICAL ASSESSMENT, AND THE CASE REPORT WILL BE SUBMITTED WITHIN 30 DAYS TO THE FDA. SENDER COMMENT: THIS EXPEDITED 15-DAY REPORTABLE CASE CONCERNS A PATIENT OF UNKNOWN AGE AND GENDER WHO WAS USING FENTANYL PATCH FOR AN UNKNOWN INDICATION AND REPORTED THAT AFTER USING FAULTY PRODUCT (DEVICE DEFECTIVE AND DEVICE MALFUNCTION), THE PATIENT WOUND UP HOSPITALIZED FOR AN OVERDOSE (DRUG OVERDOSE) AS THE PATIENT WAS FOUND UNRESPONSIVE BY FAMILY (UNRESPONSIVE TO STIMULI). THE PATIENT FOUND THAT THE LOT WAS RECALLED (RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED) AFTER THE OCCURRENCE OF THE EVENTS AND STATED THAT HE/SHE HAD MORE PATCHES ON THAN HE/SHE SHOULD HAVE BECAUSE OF THE COMPANY'S MANUFACTURING ERRORS (MANUFACTURING ISSUE).THE REPORTED EVENT OF UNRESPONSIVE TO STIMULI WAS ASSESSED AS SERIOUS AND UNLISTED. THE REPORTED EVENTS OF DRUG OVERDOSE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, MANUFACTURING ISSUE, RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED WERE ASSESSED AS SERIOUS AND LISTED. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENT OF UNRESPONSIVE TO STIMULI IS POSSIBLY RELATED. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENTS OF DRUG OVERDOSE, DEVICE DEFECTIVE, DEVICE MALFUNCTION, MANUFACTURING ISSUE, RECALLED PRODUCT AND RECALLED PRODUCT ADMINISTERED IS UNCLASSIFIED. HOWEVER, LACK OF INFORMATION REGARDING PATIENT¿S RELEVANT PAST MEDICAL HISTORY; PAST DRUG HISTORY AND FAMILY HISTORY PRECLUDES COMPREHENSIVE ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1305638 | FENTANYL | SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED | QIX | 108319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |