BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8053607 · Received November 8, 2018

    Report

    Report Number
    3009673389-2018-00003
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    July 25, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIP SURGICAL SKIN CLOSURE DEVICE WAS PLACED ON THE PATIENT'S KNEE WHILE THE KNEE WAS IN THE FULLY EXTENDED POSITION (0 DEGREES FLEXION), WHICH IS CONTRARY TO THE INFORMATION PROVIDED IN THE PRODUCT INSTRUCTIONS FOR USE. WHEN THE PATIENT FLEXED THE KNEE POST-OPERATIVELY, THE DEVICE IMMEDIATELY LOST ADHESION. LOSS OF DEVICE ADHESION AS A RESULT OF FAILURE TO FLEX THE KNEE PRIOR TO DEVICE APPLICATION IS A KNOWN RISK THAT IS DOCUMENTED IN THE PRODUCT RISK DOCUMENTATION, AS WELL AS IN THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ZIP SURGICAL SKIN CLOSURE DEVICE LOST ADHESION WHEN PATIENT FLEXED THEIR KNEE POST-OPERATIVELY. PHYSICIAN INTERVENED BY REMOVING THE DEVICE AND CLOSING THE INCISION WITH SUTURES. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890735 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS2080 0000083251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention