BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPLINE SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 7178899 · Received January 9, 2018

    Report

    Report Number
    MW5074490
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ZIPLINE MEDICAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A TOTAL KNEE REPLACEMENT ON (B)(6) 2017. THE ZIP SURGICAL SKIN CLOSURE DEVICE WAS USED FOR WOUND CLOSURE. THE REP OF THE PRODUCT WAS IN THE SURGERY AND GAVE DIRECTION DURING THE APPLICATION OF THE PRODUCT. ON (B)(6) 2017, THE PT RETURNED TO CLINIC WITH COMPLETE WOUND DEHISCENCE. THE PT WAS TAKEN BACK TO OPERATING ROOM THAT DAY FOR WASH OUT AND DEFINITIVE CLOSURE OF THE SURGICAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20861 ZIPLINE SURGICAL SKIN CLOSURE DEVICE TAPE AND BANDAGE, ADHESIVE KGX ZIPLINE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R