BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXCARE(TM) MAX HOLD WATERPROOF BANDAGES

    MDR report key: 10905161 · Received November 25, 2020

    Report

    Report Number
    2110898-2020-00060
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 30, 2020
    Report Date
    February 10, 2021
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    UDI-DI
    00051131997608
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER: UPDATED INFORMATION FOR BRAND NAME. UPDATED INFORMATION FOR CATALOG NUMBER AND UNIQUE IDENTIFIER (UDI) NUMBER.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS A 5 YEAR SHELF LIFE. NO LOT # WAS PROVIDED, THEREFORE DEVICE MANUFACTURE DATE IS UNKNOWN. NO SAMPLE HAS BEEN RECEIVED FOR ANALYSIS. THE 2-YEAR COMPLAINT HISTORY WAS REVIEWED FOR THE PRODUCT'S GLOBAL SALES CODE (GSC) OF SXJ AND REPORTED FAILURE. NO TRENDS WERE OBSERVED. 3M WILL CONTINUE TO MONITOR. TEST RESULTS CONFIRM THE BIOCOMPATIBILITY OF NEXCARE¿ WATERPROOF BANDAGES FOR THEIR INTENDED USE. IN ADDITION TO PERFORMING CLINICAL STUDIES, 3M¿ MONITORS ITS MEDICAL DEVICES WITH MANUFACTURING CONTROLS, INCLUDING IN-PROCESS SPECIFICATIONS, RELEASE SPECIFICATIONS AND TESTING. END OF REPORT.

    Description of Event or Problem · 1

    A FEMALE CUSTOMER (AGE UNSPECIFIED) ALLEGED THE NEXCARE CLEAR WATERPROOF BANDAGES CAUSED RASH TO HER BACK (EXACT LOCATION UNSPECIFIED). THE CUSTOMER STATED SHE HAD A SURGICAL PROCEDURE DONE ON HER BACK ON (B)(6) 2020, AND SHE WAS INSTRUCTED BY THE DOCTOR TO CLEANSE THE SURGICAL AREA (CUSTOMER DID NOT SPECIFY WHAT WAS USED TO CLEAN AREA), APPLY VASELINE AND COVER WITH BANDAGE. THE CUSTOMER STATED SHE CHANGED THE BANDAGE EVERY NIGHT. THE CUSTOMER ALLEGED SHE NOTICED THE RASH 72 HOURS AFTER APPLYING THE BANDAGE. SHE STATED THE FIRST COUPLE OF DAYS SHE USED THE BANDAGE, SHE WASN'T SURE IF IT WAS THE BANDAGE THAT WAS IRRITATING HER OR IF IT WAS THE SURGICAL WOUND. THE CUSTOMER REPORTED SHE INSTRUCTED HER HUSBAND TO USE RUBBING ALCOHOL AND LOTION TO SOOTHE THE ALLEGED INJURY AREA. SHE ALLEGED THE RASH IS ABOUT 6 BY 6 INCHES BEYOND THE AREA WHERE THE BANDAGE TOUCHED HER SKIN. THE CUSTOMER ALLEGED THE DOCTOR PRESCRIBED MOMETASONE 1% FOR THE ALLEGED RASH. THE CUSTOMER REPORTED SHE'S ALLERGIC TO LATEX, CODEINE, IODINE AND SALSA RUGS. NO MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369275 NEXCARE(TM) MAX HOLD WATERPROOF BANDAGES TAPE AND BANDAGE, ADHESIVE KGX 3M HEALTH CARE N/A N/A 00051131997608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other