BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8322899 · Received February 8, 2019

    Report

    Report Number
    3009673389-2019-00001
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    November 7, 2018
    Report Date
    January 3, 2019
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    UDI-DI
    00865379000033
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATA OBTAINED IN FOLLOW-UP INVESTIGATION COULD NOT ESTABLISH THAT THE EVENT WAS CAUSED BY FAILURE OF THE ZIP DEVICE. EVENT APPEARS TO HAVE OCCURRED AS A RESULT OF PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    PATIENT - PROVIDED IMAGES SHOW POTENTIAL HYPERSENSITIVITY REACTION UNDER THE FOOTPRINT OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT, DURING INPATIENT STAY FOLLOWING TOTAL KNEE ARTHROSCOPY SURGERY ON (B)(6) 2018, DEVICE OR WOUND "KEPT OPENING UP", PROMPTING SURGEON TO REMOVE (CUT OFF) INFERIOR PORTION OF ZIP DEVICE. SURGEON APPLIED 5 STAPLES TO INFERIOR END TO FACILITATE WOUND CLOSURE. ON (B)(6) 2019, PATIENT REPORTED PRESENCE OF RESIDUAL SCABS AT INFERIOR AND SUPERIOR ENDS OF WOUND SCAR THAT WERE INFLAMED WITH PRURITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116871 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1240 00865379000033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ETHICON DERMABOND (TYPE/LOT UNKNOWN)| MEPILEX BORDER WOUND DRESSING (SIZE/LOT UNKNOWN)