BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIP 16 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 4488030 · Received February 2, 2015

    Report

    Report Number
    3009673389-2015-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    December 26, 2014
    Report Date
    January 30, 2015
    Manufacturer
    ZIPLINE MEDICAL INC.
    Product Code
    KGX
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE (B)(6) DISTRIBUTOR REPORTED THE FOLLOWING EVENT: DURING A DEMONSTRATION WITH A PHYSICIAN, THE SALES REPRESENTATIVE FOUND A DEVICE WITHOUT A HEAT SEAL AT THE BOTTOM OF THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75966 ZIP 16 SURGICAL SKIN CLOSURE DEVICE ZIP 16 KGX ZIPLINE MEDICAL INC. PS1160 1002539

    Patients

    Seq Age Sex Outcome Treatment
    1