BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 20587268 · Received November 1, 2024

    Report

    Report Number
    1000599868-2024-00006
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 5, 2024
    Manufacturer
    KENVUE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4; THIS REPORT IS FOR ONE (1) BAB FLEXIBLE FABRIC ASSORTED 100 CT (B)(4), LOT/CTRL # 221123. D4: 510(K) EXEMPT DEVICE I COMPLAINT: UDI NOT REQUIRED: (B)(4). D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED AT THIS TIME; NO CONCLUSION, AT THIS TIME, COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. H6: HEALTH EFFECT CLINICAL CODES: E170401 ALSO REFERS TO CONSUMER ALLEGED " CHEMICAL BURN, BLISTERING MELTY MESS" E2402 REFERS TO CONSUMER " INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. CAN EXPECT TO HAVE A LARGE STAIN LIKE SCAR WAS A FUTURISTIC STATEMENT BASED ON INITIAL REPORTED INFORMATION, NO DIRECT REPORT OF SCAR, AS THIS TIME. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 1000599868-2024-00006 & 1000599868-2024-00007. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON NOVEMBER 23, 2022. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS IS 1 OF 2 MED-WATCH FOLLOW-UPS (BAB 01) BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES: AMP; 1000599868-2024-00007. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH FOLLOW-UP.

    Description of Event or Problem · 0

    A FEMALE CONSUMER REPORTED AN EVENT AFTER USING ONE TO TWO BAND-AID FLEXIBLE FABRIC ASSORTED BANDAGES. CONSUMER REPORTED THAT AFTER APPLYING BANDAGES TO COVER THREE STITCHES ON BACK OF LEG, THE PRODUCTS GAVE HER A DELAYED REACTION STATED TO BE A CHEMICAL BURN WHICH RESULTED, AS DESCRIBED, INTO A BLISTERING, MELTY MESS. CONSUMER REPORTED SHE WENT TO URGENT CARE AND THEN FOLLOWED UP WITH A DERMATOLOGIST. THE DERMATOLOGIST SWABBED AND SCOOPED THE BLISTERED AREA TO ASSESS FOR INFECTION. DERMATOLOGIST CONFIRMED THE CONSUMER HAD AN ALLERGIC/CHEMICAL REACTION AND WAS PRESCRIBED STEROIDS AS TREATMENT AND THERE WAS NO INFECTION. THE HEALTHCARE PROVIDER MENTIONED THAT IT WAS LIKELY TO TAKE 2-4 WEEKS TO HEAL AND CAN EXPECT TO HAVE A LARGE STAIN LIKE SCAR. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 1000599868-2024-00006 & 1000599868-2024-00007. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177213 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE 381371150786 221123

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention