BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCO FABRIC ANTIBACTERIAL 5OZ XL10 CT

    MDR report key: 5094715 · Received September 22, 2015

    Report

    Report Number
    1038758-2015-00078
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ASO LLC
    Product Code
    KGX
    PMA / PMN Number
    K983368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DATA: PER DEVICE EVALUATED BY MANUFACTURER - EVALUATION OF A REPRESENTATIVE SAMPLE OF THE RELATED MEDICAL DEVICE IS SUMMARIZED.

    Additional Manufacturer Narrative · 1

    ASO RECEIVED A SAMPLE OF THE DEVICE FROM THE CONSUMER ON 9/18/2015. ASO LAB TESTED RETURNED SAMPLES FOR ADHESION PROPERTIES ON 10/01/2015. LAB RESULTS WERE SATISFACTORY WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    08/28/15 - THE CONSUMER /END USER REPORTED THAT THE BANDAGES TORE THE SKIN OFF WHEN THE BANDAGE WAS BEING REMOVED.

    Description of Event or Problem · 1

    ASO RECEIVED A SAMPLE OF THE DEVICE FROM THE CONSUMER ON 9/18/2015. ASO LAB TESTED RETURNED SAMPLES FROM CONSUMER FOR ADHESION PROPERTIES ON 10/01/2015. RESULTS OF TEST ARE SATISFACTORY WITH NO DEFECTS FOUND WITH THE RETURNED SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627142 TOPCO FABRIC ANTIBACTERIAL 5OZ XL10 CT ADHESIVE BANDAGE KGX ASO LLC 23647

    Patients

    Seq Age Sex Outcome Treatment
    1