BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAMILY WELLNESS

    MDR report key: 6126169 · Received November 23, 2016

    Report

    Report Number
    1038758-2016-00107
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO WAS ABLE TO OBTAIN A LOT NUMBER AND PERFORMED TEST FOR ADHESION PROPERTIES FOR UNUSED RETURNED SAMPLES AS WELL AS RETAINED SAMPLES IN ADDITION TO REVIEWING TEST FOR BIOCOMPATIBILITY TESTS. ON 11/23/2016 AS CONSUMER RETURNED TWO BOXES WITH DIFFERENT LOT NUMBERS AND BRAND NAMES, ASO HAS SUBMITTED TWO DIFFERENT FORM FDA 3500A. PLEASE REFER TO MFR REPORT # 1038758-2016-00106 FOR TOPCARE STRONG STRIPS ANTIBACTERIAL BANDAGES, LOT # 00035801 AND MFR REPORT # 1038758-2016-00107 FOR FAMILY WELLNESS STRONG STRIPS ANTIBACTERIAL BANDAGES, LOT # 00049946.

    Description of Event or Problem · 1

    CONSUMER STATED THAT SHE IS ALLERGIC TO ANTIBACTERIAL BANDAGES AND SHE HAD A REACTION AFTER USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777131 FAMILY WELLNESS STRONG STRIP ANTIBACTERIAL BANDAGES KGX ASO LLC UPC#032251057830 00049946

    Patients

    Seq Age Sex Outcome Treatment
    1