BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKVISTA ACCESS BALLOON PORT 10MMX53MM

    MDR report key: 3955556 · Received June 13, 2014

    Report

    Report Number
    3003898360-2014-00383
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. HOWEVER, MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: ALLEGED ISSUE: IT WAS REPORTED THAT "TROCAR (BALLOON) BURST ON INFLATION". NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350653 WECKVISTA ACCESS BALLOON PORT 10MMX53MM BALLOON PORT GCJ 01J1300098

    Patients

    Seq Age Sex Outcome Treatment
    1