BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE BON GN BR TC-43 2N 48"

    MDR report key: 2192919 · Received July 22, 2011

    Report

    Report Number
    3004365956-2011-00284
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE IS NOT AVAILABLE. NO LOT # IS AVAILABLE. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING SURGERY THE SUTURE NEEDLE GOT CAUGHT IN THE SACROSPINOUS LIGAMENT. THE SURGEON DECIDED TO LEAVE THE NEEDLE IN THE LIGAMENT. THE PT IS REPORTED TO HAVE NOT SUFFERED ANY CONSEQUENCES AND WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE BON GN BR TC-43 2N 48" CAPIO SURGICAL SUTURE GCJ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA