BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 24 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8530126 · Received April 18, 2019

    Report

    Report Number
    3009673389-2019-00006
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 19, 2019
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER REPORT FROM SURGEON'S PARTNER, AS DOCUMENTED BY LOCAL ZIPLINE SALES REPRESENTATIVE, "POD2, DURING REHAB, 4-6 INTERRUPTED [SUBCUTANEOUS] SUTURES BROKE IN WOUND CREATING SIGNIFICANT TENSION ON SKIN CLOSURE (ZIP DEVICE). RESULTING BLEEDING FROM BROKEN [SUBCUTAENOUS] SUTURES SATURATED THE ZIP DEVICE AND CAUSE (SIC) IT TO LOSE [ADHESION]. PATIENT WAS BROUGHT BACK TO HOSPITAL AND SURGEON APPLIED STAPLES TO AFFECTED PART OF WOUND."

    Description of Event or Problem · 1

    POSTERIOR TOTAL HIP ARTHROPLASTY PATIENT REPORTED TO CLINIC ON POD 2 FOLLOWING PARTIAL LOSS OF ADHESION OF ZIP DEVICE. SURGEON INTERVENED BY REPLACING AFFECTED AREA WITH SURGICAL STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319360 ZIP 24 SURGICAL SKIN CLOSURE DEVICE TAPE-BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1240 0000109515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention