BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPCARE

    MDR report key: 8413837 · Received March 12, 2019

    Report

    Report Number
    1038758-2019-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 11, 2019
    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

    TESTING ON RETURNED PRODUCT WAS COMPARABLE TO THE STABILITY RESULTS. IN ADDITION, SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. THE PRODUCT IS LABELED AS SUPER STRENGTH ADHESIVE NOT INTENDED FOR USE ON DELICATE SKIN.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON 02/11/2019 CONSUMER STATED THAT PRODUCT TOOK HIS SKIN OFF RESULTING IN A BIG OPEN WOUND. THE CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON 02/27/2019. CONSUMER STATED THAT HE REQUIRED MEDICAL TREATMENT AND THAT THE SYMPTOMS DID NOT CORRECT AFTER HE STOPPED USING THE PRODUCT. NURSE APPLIED AN OINTMENT AND BANDAGE. IN ADDITION, CONSUMER STATED THAT THE ISSUE WAS WITH THE TAPE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206486 TOPCARE STRONG-STRIPS ADHESIVE BANDAGES KGX ASO LLC UPC#0036800103924 152332

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other