BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43/HR 26 2N

    MDR report key: 2802471 · Received October 18, 2012

    Report

    Report Number
    3004365956-2012-00297
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 26, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT SAMPLE WAS AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED THAT NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: METALLIC TIP (BULLET) BROKE OFF SUTURE AND FELL INTO PT. DESPITE A SEARCH, TIP COULD NOT BE FOUND AND IS PROBABLY STILL IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEV GN BR 0 TC-43/HR 26 2N CAPIO SUTURE GAW TELEFLEX MEDICAL 02A1202112

    Patients

    Seq Age Sex Outcome Treatment
    1