BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 16 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 4346035 · Received December 11, 2014

    Report

    Report Number
    3009673389-2014-00001
    Event Type
    Injury
    Date Received
    December 11, 2014
    Date of Event
    November 4, 2014
    Report Date
    December 10, 2014
    Manufacturer
    ZIPLINE MEDICAL INC.
    Product Code
    KGX
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR: THIS WAS THE FIRST USAGE OF THE ZIP DEVICE BY THE SURGEON. THE EVENT MAY HAVE OCCURRED DUE TO TECHNICAL OPERATIVE KNOWLEDGE OR THE PATIENT'S IMPROPER CARE. ZIPLINE REQUESTED ADDITIONAL INFORMATION REGARDING USAGE OF THE DEVICE AND THE PATIENT POST-OPERATIVE CARE. THE INFORMATION PROVIDED WAS INCONCLUSIVE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, SO IT COULD NOT BE DETERMINED IF THE ADHESIVE, LOCKS OR STRAPS FAILED TO MEET SPECIFICATIONS. A REVIEW OF THE FINAL DEVICE HISTORY RECORD DID NOT IDENTIFY ANY ISSUES THAT CORRELATED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR REPORTED THE FOLLOWING EVENT: THE LOCK OPENED TWICE AFTER SURGERY AND THE SURGEON HAD TO RE-LOCK THE DEVICE. IN SPITE OF USING A BANDAGE, BLOOD WAS COMING OUT OF THE WOUND AND THE DEVICE COULD NOT BE CLOSED PROPERLY. ON THE FIFTH DAY AFTER SURGERY, THE GLUE BECAME INEFFECTIVE AND THE DEVICE STARTED TO LIFT FROM THE SKIN. THE SURGEON REMOVED THE DEVICE AND CLOSED THE INCISION WITH STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803740 ZIP 16 SURGICAL SKIN CLOSURE DEVICE ZIP 16 KGX ZIPLINE MEDICAL INC. PS1160 1002719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention