BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND BREATHABLE BANDAGES AP 1361CAP

    MDR report key: 12169865 · Received July 14, 2021

    Report

    Report Number
    1000599868-2021-00011
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 20, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    KGX
    UDI-DI
    6916999000713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., 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 DECEMBER 13, 2020. THIS IS 2 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED, AS IT WAS UNKNOWN WHICH BAND-AID PRODUCT WAS INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2021-00010. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED, AS IT WAS UNKNOWN WHICH BAND-AID PRODUCT WAS INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2021-00010. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR BAND-AID BREATHABLE 16CT (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. BAND-AID BREATHABLE 16CT AP (B)(4) IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB SHEER 1INX3IN (B)(4)). UDI #: (B)(4). UPC #: 6916999000713. LOT #:201213. EXP: NA. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB SHEER 1INX3IN USA (B)(4) ). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAVE BEEN REQUESTED. THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED, AS IT WAS UNKNOWN WHICH BAND-AID PRODUCT WAS INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2021-00010. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS INITIAL MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A CONSUMER REPORTED AN EVENT WITH BAND AID BRAND BREATHABLE BANDAGES. THE CONSUMER¿S FINGER WAS CUT, AND TWENTY MINUTES AFTER TREATING THE FINGER WITH A BANDAGE, A RED RASH APPEARED, AND SITE WAS ITCHY AROUND THE WOUND. THE BANDAGE WAS IMMEDIATELY REMOVED. IT WAS ASSESSED THAT THE MEDICAL EVENT WAS CAUSED BY THE PRODUCT. CONSUMER REMOVED THE BANDAGE, DISINFECTED THE SITE WITH IODOPHOR AND IMMEDIATELY WENT TO HOSPITAL. NO FURTHER INFORMATION REGARDING TREATMENT RECEIVED FROM THE HOSPITAL. THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED, AS IT WAS UNKNOWN WHICH BAND-AID PRODUCT WAS INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2021-00010. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064868 BAND AID BRAND BREATHABLE BANDAGES AP 1361CAP TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. 6916999000713 201213 6916999000713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention