BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPLINE 3

    MDR report key: 2654767 · Received June 12, 2012

    Report

    Report Number
    MW5026135
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 18, 2012
    Manufacturer
    ZIPLINE MEDICAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS PLACED ON CHEST OF MALE PT ON (B)(6) FOR CLOSURE OF A 1 X 2 CM EXCISION. ON (B)(6) THE DEVICE DETACHED FROM THE WOUND. THE WOUND WAS DEHISCED. DEBRIDEMENT WAS PERFORMED ON THE WOUND AND TWO PROLENE SUTURES WERE APPLIED TO COMPLETE THE CLOSURE OF THE WOUND. IT WAS DISCOVERED THAT THE PHYSICIAN APPLIED AN ANTIBIOTIC PETROLEUM BASED OINTMENT (BACITRACIN) TO THE WOUND AFTER THE DEVICE WAS APPLIED. ENGINEERING EVAL OF ANTIBIOTIC PETROLEUM BASED OINTMENT WHEN USED WITH THE DEVICE CONFIRMED THE FAILURE EXPERIENCED BY THE PT/PHYSICIAN. THIS INFO IS CAPTURED IN THE MFR CORRECTIVE AND PREVENTATIVE ACTION PROCEDURE (B)(4). THE INSTRUCTION FOR USE (IFU) FOR THE DEVICE HAS BEEN UPDATED TO STATE A PRECAUTION IN USING PETROLEUM BASED OINTMENTS. THIS UPDATE WAS RELEASED UNDER THE MFR CHANGE ORDER SYSTEM (B)(4). LOCATION WHERE EVENT OCCURRED: OUTPATIENT TREATMENT FACILITY. DEVICE MANUFACTURE DATE: 03/21/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPLINE 3 WOUND CLOSURE DEVICE KGX ZIPLINE MEDICAL, INC. PS1001 120355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention