BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE

    MDR report key: 5431671 · Received February 11, 2016

    Report

    Report Number
    3009673389-2016-00002
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    November 26, 2015
    Report Date
    February 10, 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

    NO ADDITIONAL INFORMATION COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED POST-OP 1 WEEK. PATIENT WAS TREATED FOR A WOUND INFECTION (POST-OP DATE AND SOURCE OF INFECTION UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89215 ZIP SURGICAL SKIN CLOSURE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1160 1002894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention