BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE

    MDR report key: 1241617 · Received November 19, 2008

    Report

    Report Number
    3004365956-2008-00072
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 31, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION REPORT IS NOT YET AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: THAT DURING THE PROCEDURE, THE BULLET CAME OFF THE DEVICE. NO PATIENT INJURY OR INTERVENTION REPORTED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE SUTURE GAW TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA