BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOURE

    MDR report key: 5431651 · Received February 11, 2016

    Report

    Report Number
    3009673389-2016-00001
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    November 11, 2015
    Report Date
    May 5, 2016
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR REPORTING THAT THERE WAS FLUID COMING FROM THE WOUND. AS WITH ANY TAPE BASED ADHESIVE, THE SKIN MUST BE CLEAN AND DRY WHEN APPLYING THE DEVICE IN ORDER TO ACHIEVE PROPER ADHESION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE ZIP DEVICE DID NOT REMAIN AFFIXED TO THE SKIN. THE SURGEON REMOVED THE DEVICE AND CLOSED THE WOUND WITH SUTURES. (2 HOURS POST-OP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87240 ZIP SURGICAL SKIN CLOURE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1160 1002894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention