BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 24 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8529978 · Received April 18, 2019

    Report

    Report Number
    3009673389-2019-00004
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 12, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE USER FACILITY VOLUNTARY EMDR REPORT NUMBER MW5085080. SUBCUTANEOUS INCISION CLOSURE WAS PERFORMED USING RUNNING BARBED SUTURES. SURFACE CLOSURE WAS COMPLETED USING SURGICAL STAPLES AND THE ZIPSEAL 24 SURGICAL SKIN CLOSURE CONVENIENCE KIT, WHICH CONSISTS OF THE ZIP 24 SURGICAL SKIN CLOSURE DEVICE (SUSPECT MEDICAL DEVICE) AND THE CARDINAL HEALTH TOPICAL SKIN ADHESIVE (CONCOMITANT MEDICAL PRODUCT). BASED UPON REVIEW OF PATIENT PHOTOGRAPHIC IMAGE AND ACCOUNTS PROVIDED BY MEDICAL STAFF AND ZIPLINE SALES REPRESENTATIVE WHO PERFORMED STAFF TRAINING/INSERVICE, THE ZIP DEVICE LOST PARTIAL ADHESION OF HYDROCOLLOID STRIPS AS A RESULT OF CONTAMINATION WITH BLOOD/BODY FLUIDS ON POD 1. FAILURE HAS BEEN ATTRIBUTED TO A COMBINATION OF INADEQUATE SUTURING AND OVERTIGHTENING OF THE ZIP DEVICE STRAPS. [VOLUNTARY USER FACILITY REPORT MW5085080.PDF].

    Description of Event or Problem · 1

    TOTAL KNEE ARTHROPLASTY PATIENT WAS RE-ADMITTED TO OPERATING ROOM FOR RE-CLOSURE OF SURGICAL INCISION AS A RESULT OF ADHESION LOSS AND PARTIAL MIGRATION OF ZIP DEVICE. SEE VOLUNTARY REPORT NUMBER MW5085080 GENERATED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320163 ZIP 24 SURGICAL SKIN CLOSURE DEVICE TAPE-BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1240 0000110434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention