BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 7870209 · Received September 12, 2018

    Report

    Report Number
    3009673389-2018-00002
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE IS NOT POSSIBLE, AS AFFECTED DEVICE WAS DISCARDED BY PHYSICIAN UPON REMOVAL AND WILL NOT BE DELIVERED TO MANUFACTURER FOR ANALYSIS. PER INFORMATION PROVIDED BY THE PHYSICIAN TO THE ZIPLINE SALES REP, THE PATIENT EXPERIENCED EXCESSIVE FLUID DRAINAGE THAT RESULTED IN "CONTINUAL DRESSING CHANGES" ON POD 1. INVESTIGATION HAS DETERMINED, BASED UPON DESIGN VERIFICATION TESTING AND HISTORICAL COMPLAINT DATA, THAT EXPOSURE TO EXCESS FLUIDS ADVERSELY AFFECTS THE ABILITY OF THE ZIP DEVICE TO MAINTAIN SKIN ADHESION. THE PRODUCT INSTRUCTIONS FOR USE PROVIDE CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS THAT NOTIFY THE USER THAT THE DEVICE IS NOT INTENDED TO BE EXPOSED TO EXCESSIVE MOISTURE.

    Description of Event or Problem · 1

    FOLLOWING PLACEMENT OF AN UNIDENTIFIED ZIP SURGICAL SKIN CLOSURE DEVICE FOR CLOSURE OF A TOTAL KNEE ARTHROSCOPY INCISION, IT WAS REPORTED ON POD1 THAT "PATIENT WAS DRAINING FROM INCISION AND NEEDED CONTINUAL DRESSING CHANGES. BOTTOM 4 STRAPS OF ZIP [DEVICE] LOST ADHESION TO SKIN." THE SECTION OF THE ZIP DEVICE THAT HAD LOST ADHESION WAS REMOVED BY THE PHYSICIAN, WHO INTERVENED BY CLOSING THE INCISION WITH 5 STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712062 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention