BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE

    MDR report key: 8444052 · Received March 21, 2019

    Report

    Report Number
    MW5085077
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 19, 2019
    Manufacturer
    ZIPLINE MEDICAL, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ZIP SURGICAL CLOSURE DEVICE FAILED POST OP AFTER PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234724 ZIP SURGICAL SKIN CLOSURE TAPE AND BANDAGE, ADHESIVE KGX ZIPLINE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization