BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENTANYL

    MDR report key: 22689408 · Received August 1, 2025

    Report

    Report Number
    2010441-2025-00005
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 1, 2025
    Product Code
    QIX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REPORT NUMBER: 2010441-2025-00005, WILL BE SUBMITTED AS A INITIAL 30-DAY REPORT WITH RECEIPT DATE (DAY 0): 04-JUL-2025 BY REMOVING MOST RECENT INFORMATION LOGS FROM THE CASE. THE INITIAL VERSION (30-DAY) AND FOLLOW-UP VERSION 1 (30-DAY) OF THE CASE WERE RECEIVED ON 06-MAY-2025 AND 09-MAY-2025, RESPECTIVELY. THE INITIAL AND FU1 VERSIONS WERE SUBMITTED ON 19-MAY-2025 AND 02-JUN-2025, RESPECTIVELY. THESE CASE VERSIONS WERE SUBMITTED AS AN E2B R2 XML FILE ALONG WITH MDR FORM IN PDF FILE FORMAT VIA THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) AS2. ON 04-JUL-2025, DEVICE EVALUATION REPORT WAS RECEIVED IN FOLLOW UP VERSION 2. AS THE PREVIOUS CASE VERSIONS WERE NOT SUBMITTED AS XML HL7 FILE, HENCE AFTER SUBMISSION OF THE INFORMATION RECEIVED ON 04-JUL-2025, A NEGATIVE ACKNOWLEDGMENT WAS RECEIVED STATING "INITIAL REPORT/PRIOR SUPPLEMENT HAS NOT BEEN RECEIVED. THE INITIAL REPORT AND SUPPLEMENTS 1 IS MISSING". THEREFORE, THE INFORMATION RECEIVED ON 06-MAY-2025 AND 09-MAY-2025 WILL BE SUBMITTED AS INITIAL REPORT WITH THE RECEIPT DATE (DAY 0): 04-JUL-2025 AS A SINGLE REPORT.

    Description of Event or Problem · 0

    MFR REPORT #: (B)(4). #1: ANXIETY ATTACK V28.0 (PHYSICIAN DIAGNOSED THE SHORTNESS OF BREATH AS AN ANXIETY ATTACK): FROM (B)(6) 2025 TO - SERIOUS - NOT RECOVERED/NOT RESOLVED. #2: FEELING HOT V28.0 (PATIENT HAD MULTIPLE EPISODES OF FEELING OVERHEATED): FROM (B)(6) 2025 TO - NOT SERIOUS - UNKNOWN. #3: DEPRESSED MOOD V28.0 (FEELING DEPRESSED): FROM (B)(6) 2025 TO - NOT SERIOUS - UNKNOWN. #4: DIFFICULTY SLEEPING V28.0 (PATIENT WAS HAVING TROUBLE SLEEPING): FROM (B)(6) 2025 TO - NOT SERIOUS - NOT RECOVERED/NOT RESOLVED. THIS SPONTANEOUS CASE REPORT 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 A 46-YEAR-OLD ADULT FEMALE PATIENT WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR SEVERE PAIN IN NECK, RIGHT SHOULDER, DOWN IN HER RIGHT ARM AND GABAPENTIN FOR UNKNOWN INDICATION AND SHE BEGAN EXPERIENCING EPISODES OF SHORTNESS OF BREATH ABOUT TWO WEEKS AFTER STARTING FENTANYL PATCHES AND SHE COULD NOT CATCH BREATH IN THE FOLLOWING WEEKS AND LATER PHYSICIAN DIAGNOSED THE SHORTNESS OF BREATH AS AN ANXIETY ATTACK (PT: ANXIETY). PATIENT ALSO HAD TROUBLE SLEEPING (PT: INSOMNIA), MULTIPLE EPISODES OF FEELING OVERHEATED (PT: FEELING HOT) AND FELT DEPRESSED (PT: DEPRESSED MOOD) (CLINICAL TERM: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS; PROBLEM TERM: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM). RELEVANT MEDICAL HISTORY INCLUDED BREAST AUGMENTATION. FAMILY HISTORY AND PAST DRUG HISTORY WERE NOT REPORTED. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE ABNORMAL AND MIGRAINE HEADACHE. SHE FURTHER STATED THAT SHE HAD A DISC THAT WAS BULGING, AND HAD SEVERE PAIN IN NECK, RIGHT SHOULDER AND DOWN IN HER RIGHT ARM. CONCOMITANT MEDICATION INCLUDED IRBESARTAN 150 MG ONCE A DAY FOR BLOOD PRESSURE. CO-SUSPECT MEDICATION INCLUDED GABAPENTIN 600 MG 3 TIMES A DAY FOR AN UNKNOWN INDICATION. ON (B)(6) 2025, THE PATIENT STARTED TREATMENT WITH FENTANYL (SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED, APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) TRANSDERMAL PATCH AT 25MCG/HR (BATCH/LOT NUMBER: 108319, EXPIRATION DATE: UU-APR-2027, DEVICE MANUFACTURE DATE: UNKNOWN) AND LATER PRIMARY DOCTOR REDUCED THE DOSE TO 12MCG/HR FOR SEVERE PAIN IN NECK, RIGHT SHOULDER AND DOWN IN HER RIGHT ARM (BATCH/LOT NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN). USAGE OF THE DEVICE WAS UNKNOWN, AND THE OPERATOR OF DEVICE WAS PATIENT. PATIENT CONTACTED REGARDING THE RECALL ON THE FENTANYL TRANSDERMAL PATCHES. PATIENT BEGAN USING FENTANYL AND EXPERIENCED EPISODES OF SHORTNESS OF BREATH ABOUT TWO WEEKS AFTER. PATIENT ALSO HAD TROUBLE SLEEPING AND WAS FEELING DEPRESSED. PATIENT HAD MULTIPLE EPISODES OF FEELING OVERHEATED AND COULD NOT CATCH THE BREATH IN THE FOLLOWING WEEKS. PATENT HAD TO LEAVE IN THE MIDDLE OF A DENTIST APPOINTMENT DUE TO ONE OF THESE SYMPTOMS. FURTHER MENTIONED THAT PATIENT DID NOT HAVE THESE SYMPTOMS PRIOR TO THE PATCH. ON 27-JAN-2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO SHORTNESS OF BREATH. THE PHYSICIAN DIAGNOSED THE SHORTNESS OF BREATH AS AN ANXIETY ATTACK. PATIENT NOTICED THAT THE SYMPTOMS PEAKED ON DAY 3 OF THE PATCH EACH WEEK. PATIENT SPOKE TO MULTIPLE MEDICAL PROFESSIONALS WHO SUGGESTED THAT THE SYMPTOMS WERE RELATED TO THE BODY'S RESPONSE TO COMING DOWN OFF OF THE PATCH. ON (B)(6) 2025, THE PATIENT CALLED THE DOCTOR TO INITIATE WEANING OFF THE PATCH DUE TO THE SIDE EFFECTS CAUSED BY THE PATCH. THE PRIMARY DOCTOR DECREASED THE DOSE TO 12MCG/HOUR. PATIENT WAS THEN CONTACTED BY THE PHARMACY, AND WAS INFORMED THAT THERE WAS A RECALL ON THE 25MCG/HR FENTANYL PATCHES THAT PATIENT RECEIVED FROM THEM. PATIENT HAD BEEN OFF OF ALL FENTANYL THEN FOR OVER TWO MONTHS AND STILL HAD SPORADIC EPISODES OF ANXIETY ATTACKS AND STILL HAD TROUBLE SLEEPING. ON (B)(6) 2025, PATIENT STATED THAT PATIENT WAS INFORMED BY PHARMACY THAT THERE WAS A RECALL ON PATCHES DUE TO THE PATCHES BEING DOUBLE STACKED. PATIENT FURTHER PROVIDED PRODUCT AND PHARMACY DETAILS. ON (B)(6) 2025, PATIENT STATED THAT SHE DID NOT NOTICE IF THE PATCHES OVERLAYED OR OVER STACKED IN THE APPEARANCE, BUT SHE EXPERIENCED SIDE EFFECTS FROM MIDWAY THROUGH THE MONTH OF (B)(6) 2025. SHE FURTHER CONFIRMED THAT FENTANYL BOX WAS SEALED AND THERE WAS NO SIGN OF TAMPERING OF THE BOX. SHE MENTIONED THAT SHE ADMITTED FOR 1 DAY ON (B)(6) 2025 AND THEY DID EKG, SOME BLOOD WORK AND PHYSICAL EXAMINATION LIKE THEY WOULD NORMALLY DO. SHE CONFIRMED THAT SHE WAS NOT USING ANY OTHER STRENGTHS OF THE FENTANYL PATCH OR OTHER PATCHES THAT SHE WAS USING, AND SIDE EFFECTS WERE NOT GONE AWAY COMPLETELY BECAUSE SHE WAS STILL EXPERIENCING ANXIETY AND TROUBLE SLEEPING. SHE ALSO CONFIRMED THAT HER PHYSICIAN WAS AWARE ABOUT THIS ISSUE. ON (B)(6) 2025, INVESTIGATION SUMMARY REPORT REVEALED THAT NO SAMPLE WAS RETURNED DURING THE TIME OF COMPLAINT. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION IS PROVIDED, THE FILE IS REVIEWED TO DETERMINE IF FURTHER INVESTIGATION IS NEEDED. BATCH RECORD REVIEW FOR THE REPORTED COMPLAINTS WAS COMPLETED AND THERE WAS NO MANUFACTURING ISSUES NOTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE CAUSE OF 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. PHARMACOVIGILANCE TRIAGE AND REPORTING ARE THE RESPONSIBILITY OF COMPANY. NO FURTHER ACTION FOR KINDEVA. NO CORRECTIVE ACTION/ PREVENTIVE ACTION WILL BE RAISED AT THIS TIME (METHOD TERM: TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER, RESULT TERM: NO DEVICE PROBLEM FOUND, CONCLUSION TERM: DEVICE PROBLEM EXCLUDED). 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. THE CASE IS CONSIDERED AS SERIOUS (HOSPITALISATION OR PROLONGATION OF EXISTING HOSPITALISATION AND OTHER MEDICALLY IMPORTANT CONDITION) FOR THE EVENT ANXIETY AND NON-SERIOUS FOR REST OF THE EVENTS (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) TRANSDERMAL PATCH WAS DRUG WITHDRAWN ON (B)(6) 2025 AND WITH GABAPENTIN WAS UNKNOWN. THE OUTCOME OF THE EVENT INSOMNIA AND ANXIETY WAS NOT RECOVERED AND OF THE REST OF THE EVENTS WAS UNKNOWN. THE REPORTER¿S ASSESSMENT OF THE CAUSAL RELATIONSHIP OF THE EVENTS WITH THE FENTANYL TRANSDERMAL PATCH AND GABAPENTIN WAS PROVIDED AS POSSIBLE AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW UP INFORMATION 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. REPORTER'S DETAILS, PATIENT'S DETAILS (AGE, GENDER, AGE GROUP), MD OPERATOR DETAILS, RELEVANT MEDICAL HISTORY (BREAST AUGMENTATION), CONCURRENT CONDITIONS, SERIOUSNESS CRITERIA FOR THE EVENT OF ANXIETY (HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION), CONCOMITANT MEDICATION (IRBESARTAN), CO-SUSPECT MEDICATION (GABAPENTIN), INDICATION OF SUSPECT PRODUCT, DATE OF LAST ADMINISTRATION OF SUSPECT PRODUCT FENTANYL AND LABORATORY TESTS WERE ADDED. ONSET DATE OF ALL EVENTS (FROM UU-UUU-2025 TO UU-JAN-2025) WAS UPDATED. THE NARRATIVE WAS UPDATED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW UP INFORMATION WAS RECEIVED FROM PRODUCT QUALITY GROUP FROM UNITED STATES ON (B)(6) 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 (30-DAY) AND FOLLOW-UP VERSION 1 (30-DAY) OF THE CASE WERE RECEIVED ON 06-MAY-2025 AND 09-MAY-2025, RESPECTIVELY. THE INITIAL AND FU1 VERSIONS WERE SUBMITTED ON 19-MAY-2025 AND 02-JUN-2025, RESPECTIVELY. THESE CASE VERSIONS WERE SUBMITTED AS AN E2B R2 XML FILE ALONG WITH MDR FORM IN PDF FILE FORMAT VIA THE ELECTRONIC SUBMISSIONS GATEWAY (ESG) AS2. ON 04-JUL-2025, DEVICE EVALUATION REPORT WAS RECEIVED IN FOLLOW UP VERSION 2. AS THE PREVIOUS CASE VERSIONS WERE NOT SUBMITTED AS XML HL7 FILE, HENCE AFTER SUBMISSION OF THE INFORMATION RECEIVED ON 04-JUL-2025, A NEGATIVE ACKNOWLEDGMENT WAS RECEIVED STATING "INITIAL REPORT/PRIOR SUPPLEMENT HAS NOT BEEN RECEIVED. THE INITIAL REPORT AND SUPPLEMENTS 1-3 ARE MISSING". THEREFORE, THE INFORMATION RECEIVED ON 06-MAY-2025 AND 09-MAY-2025 WILL BE SUBMITTED AS INITIAL REPORT WITH THE RECEIPT DATE (DAY 0): 04-JUL-2025 AS A SINGLE REPORT. MDR COMMENT: ACCORDING TO THE MEDICAL ASSESSMENT, A 46-YEAR-OLD FEMALE PATIENT USING FENTANYL TRANSDERMAL PATCHES FOR SEVERE PAIN IN NECK, RIGHT SHOULDER, DOWN IN HER RIGHT ARM AND GABAPENTIN FOR UNKNOWN INDICATION BEGAN EXPERIENCING EPISODES OF SHORTNESS OF BREATH ABOUT TWO WEEKS AFTER STARTING FENTANYL PATCHES AND SHE COULD NOT CATCH BREATH IN THE FOLLOWING WEEKS AND LATER PHYSICIAN DIAGNOSED THE SHORTNESS OF BREATH AS AN ANXIETY ATTACK (ANXIETY). PATIENT ALSO HAD TROUBLE SLEEPING (INSOMNIA), MULTIPLE EPISODES OF FEELING OVERHEATED (FEELING HOT) AND FELT DEPRESSED (DEPRESSED MOOD). FURTHER IT WAS REPORTED THAT PATIENT DID NOT NOTICE IF THE PATCHES WERE OVERLAYED OR OVER STACKED IN THE APPEARANCE. ADDITIONALLY, INVESTIGATION SUMMARY REPORT REVEALED THAT NO SAMPLE WAS RETURNED DURING THE TIME OF COMPLAINT. BATCH RECORD REVIEW FOR THE REPORTED COMPLAINTS WAS COMPLETED AND THERE WAS NO MANUFACTURING ISSUES NOTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE CAUSE OF THE ALLEGED COMPLAINT HENCE, NO FURTHER ACTION WAS REQUIRED. THE OCCURRENCE OF SERIOUS EVENT OF SHORTNESS OF BREATH WHICH WAS SUBSEQUENTLY DIAGNOSED AS ANXIETY ATTACK WAS DUE TO THE USE OF FENTANYL PATCH THAT WAS LATER CONFIRMED TO BE A PART OF RECALLED LOT. ADDITIONALLY, AS THE COMPANY HAD ALREADY COMPLETED A REMEDIAL ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH AND HAVE FILED 5-DAY REPORTS PREVIOUSLY FOR THE EVENTS THAT LED THE COMPANY TO RECOGNIZE THE NEED FOR THE REMEDIAL ACTION OF RECALL. THE RECALL WAS COMPLETED PRIOR TO THE COMPANY BECOMING AWARE OF THIS REPORT. THEREFORE, THE SUBSEQUENT ADDITIONAL REPORTABLE EVENT (INCLUDING THE CURRENT REPORT) ASSOCIATED WITH THE REMEDIAL ACTION (I.E., EVENTS THAT DO NOT NECESSITATE A NEW REMEDIAL ACTION) WOULD BE FILED AS 30-DAY REPORT. HENCE, AS THERE IS A REASONABLE POSSIBILITY OF PRODUCT RELATED HARM, HENCE THE CASE QUALIFIES TO BE 30-DAY REPORTABLE CASE IN ACCORDANCE WITH REGULATORY GUIDELINES. SENDER COMMENT: THIS 30-DAY REPORTABLE CASE CONCERNS A 46-YEAR-OLD ADULT FEMALE PATIENT WHO WAS ON A TREATMENT WITH FENTANYL TRANSDERMAL PATCHES FOR SEVERE PAIN IN NECK, RIGHT SHOULDER, DOWN IN HER RIGHT ARM AND GABAPENTIN FOR UNKNOWN INDICATION AND SHE BEGAN EXPERIENCING EPISODES OF SHORTNESS OF BREATH ABOUT TWO WEEKS AFTER STARTING FENTANYL PATCHES AND SHE COULD NOT CATCH BREATH IN THE FOLLOWING WEEKS AND LATER PHYSICIAN DIAGNOSED THE SHORTNESS OF BREATH AS AN ANXIETY ATTACK (ANXIETY ATTACK). PATIENT ALSO HAD TROUBLE SLEEPING (DIFFICULTY SLEEPING), MULTIPLE EPISODES OF FEELING OVERHEATED (FEELING HOT) AND FELT DEPRESSED (DEPRESSED MOOD). THE EVENT OF ANXIETY ATTACK WAS ASSESSED AS SERIOUS AND LISTED FOR FENTANYL. THE EVENT OF FEELING HOT WAS ASSESSED AS NON-SERIOUS AND UNLISTED FOR FENTANYL. THE EVENTS OF DIFFICULTY SLEEPING AND DEPRESSED MOOD WERE ASSESSED AS NON-SERIOUS AND LISTED FOR FENTANYL. THE EVENT OF ANXIETY ATTACK WAS ASSESSED AS SERIOUS AND LISTED FOR GABAPENTIN. THE EVENT OF FEELING HOT WAS ASSESSED AS NON-SERIOUS AND UNLISTED FOR GABAPENTIN. THE EVENTS OF DIFFICULTY SLEEPING AND DEPRESSED MOOD WERE ASSESSED AS NON-SERIOUS AND LISTED FOR GABAPENTIN. THE CAUSAL ROLE OF FENTANYL FOR THE REPORTED EVENTS OF FEELING HOT, ANXIETY ATTACK, DIFFICULTY SLEEPING AND DEPRESSED MOOD IS ASSESSED AS POSSIBLY RELATED. THE CAUSAL ROLE OF GABAPENTIN FOR THE REPORTED EVENTS OF FEELING HOT, ANXIETY ATTACK, DIFFICULTY SLEEPING AND DEPRESSED MOOD IS ASSESSED AS POSSIBLY RELATED. HOWEVER, MULTIPLE OTHER CONFOUNDERS HAVE BEEN IDENTIFIED INCLUDING PATIENT'S CONCURRENT CONDITIONS OF BLOOD PRESSURE ABNORMAL, MIGRAINE, HEADACHE, BULGING DISC, SEVERE PAIN IN NECK, RIGHT SHOULDER AND DOWN IN HER RIGHT ARM; PATIENT'S MEDICAL HISTORY INCLUDED BREAST AUGMENTATION AND PATIENT'S CONCOMITANT MEDICATION IRBESARTAN WHICH PRECLUDES COMPREHENSIVE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025237 FENTANYL SYSTEM, TRANSDERMAL DELIVERY, CDER OR CBER LED QIX 108319, UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other| H IRBESARTAN.