BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND ADVANCED HEALING BANDAGES

    MDR report key: 15567137 · Received October 7, 2022

    Report

    Report Number
    2214133-2022-00045
    Event Type
    Injury
    Date Received
    October 7, 2022
    Report Date
    September 14, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THIS REPORT IS FOR ONE (BAND AID BRAND ADVANCED HEALING BANDAGES UNSPECIFIED AP NOTAPPLICABLE BABAHBUNSPECAPA BABAHBUNSPECAPA, LOT/CTRL # N/A). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA 8137117533USA). LOT NUMBER WAS NOT AVAILABLE. . DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A DAUGHTER REPORTED AN EVENT FOR HER FATHER REGARDING UNSPECIFIED BAND AID BRAND ADVANCED HEALING BANDAGE. THE CONSUMER IS MALE AND 93 YEARS OLD. THE CONSUMER¿S DAUGHTER REPORTED THAT HER FATHER HAS VERY FRAGILE SKIN. ON AN UNSPECIFIED DATE, AN UNDISCLOSED PERSON APPLIED UNSPECIFIED BAND AID BRAND ADVANCED HEALING BANDAGE ON THE CONSUMER¿S WOUND. THE LOCATION OF THE WOUND WAS NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER DEVELOPED CELLULITIS WHILE THE BANDAGE WAS IN USE. ON AN UNSPECIFIED DATE, THE CONSUMER WAS TAKEN TO HOSPITAL WHERE SALINE SOLUTION WAS APPLIED TO TRY AND REMOVE THE BANDAGE WITH MINIMAL SUCCESS. ANOTHER LIQUID (UNSPECIFIED) WAS APPLIED TO DISSOLVE THE ADHESIVE. APPROXIMATELY HALF OF THE BANDAGE WAS ABLE TO BE REMOVED, HOWEVER THE SKIN WAS DAMAGED DURING THE REMOVAL AND THE DOCTORS STOPPED TRYING TO REMOVE IT FURTHER. THE CONSUMER STATED THAT A LARGE SKIN FLAP WAS LEFT BEHIND. AT THE TIME OF THE CALL, THE PATIENT WAS WAITING TO BE REVIEWED BY THE PLASTIC SURGICAL TEAM TO DISCUSS REMOVAL OF THE REMAINING PRODUCT. OUTCOME OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236359 BAND AID BRAND ADVANCED HEALING BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Required Intervention