BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 16 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 4990580 · Received August 5, 2015

    Report

    Report Number
    3009673389-2015-00004
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    March 13, 2015
    Report Date
    July 31, 2015
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE DISTRIBUTOR CONTACTED ZIPLINE ASKING FOR ADVICE REGARDING USE OF PREVAIL SOLUTION WITH RESPECT TO ZIP DEVICE ADHESION PROBLEMS. NO OTHER DETAILS WERE PROVIDED. ON (B)(6) 2015, THE DISTRIBUTOR REPORTED THE FOLLOWING ADDITIONAL DETAILS: THE ZIP DEVICE WAS NOT USED CORRECTLY. THE RESIDENT DID NOT CLEAN THE INCISION AS INSTRUCTED PRIOR TO APPLYING THE ZIP DEVICE. HE THEN APPLIED AN ISLAND DRESSING OVER THE ZIP DEVICE IN A MANNER CONTRARY TO THE IFU AND INSTRUCTIONS GIVEN BY THE DISTRIBUTOR. ON THE FOLLOWING DAY, BECAUSE THE DRESSING WAS DIRECTLY ADHERED TO THE ZIP DEVICE, THE ZIP DEVICE CAME OFF WHEN THE ISLAND DRESSING WAS REMOVED. STERI-STRIPS WERE APPLIED OVER THE INCISION. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519235 ZIP 16 SURGICAL SKIN CLOSURE DEVICE TAPE AND BANDAGE ADHESIVE KGX ZIPLINE MEDICAL PS1160 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention