BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE TEV GN BR 0

    MDR report key: 1762788 · Received June 25, 2010

    Report

    Report Number
    3004365956-2010-00086
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 1, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. INVESTIGATION REPORT IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THIS EVENT WAS ALSO RECEIVED VIA A MEDWATCH FROM FDA. THE EVENT IS DESCRIBED AS: THE NEEDLE FROM 2 DIFFERENT CAPIO SUTURES DETACHED INSIDE PATIENT WHEN PHYSICIAN WAS THROWING THE SUTURES THROUGH THE PATIENT'S SACROSPINOUS LIGAMENT. ONLY ONE CAPIO CL DEVICE WAS USED WITH BOTH SUTURES. PHYSICIAN DECIDED TO NOT RETRIEVE NEEDLES INSIDE THE PATIENT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE TEV GN BR 0 CAPIO SUTURE GAK TELEFLEX MEDICAL NA 02H0901070

    Patients

    Seq Age Sex Outcome Treatment
    1