BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPLINE 3

    MDR report key: 2654766 · Received June 12, 2012

    Report

    Report Number
    MW5026134
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 18, 2012
    Manufacturer
    ZIPLINE MEDICAL, INC.
    Product Code
    KGX
    Product Problem
    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 A MALE PT ON (B)(6), FOR CLOSURE ON A 1 X 3 CM EXCISION. ON (B)(6), THE PT NOTICED THAT THE DEVICE DETACHED FROM THE WOUND AREA. THE PT MET WITH THE PHYSICIAN FOR EXAMINATION OF THE WOUND AREA. THE PHYSICIAN DETERMINED THAT THE WOUND WAS HEALING PROPERLY. TO COMPLETE THE HEALING PROCESS, THE PHYSICIAN PLACED WOUND DRESSING ACROSS THE WOUND. IT WAS DISCOVERED THAT THE PT APPLIED AN ANTIBIOTIC PETROLEUM BASED OINTMENT (POLYSPORIN) TO THE WOUND AFTER THE DEVICE WAS APPLIED BY THE PHYSICIAN. 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 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. MANUFACTURE DATE: 03/21/2012. (B)(4).

    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 *