BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE DEVICE

    MDR report key: 1083591 · Received July 29, 2008

    Report

    Report Number
    3004365956-2008-00031
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Report Date
    July 16, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE RETURNED FOR EVAL. AWAITING INVESTIGATION REPORT AND DHR REVIEW ON LOT#.

    Description of Event or Problem · 1

    RECEIVED A COPY OF MEDWATCH FROM FDA ON 07/16/2008. INCIDENT REPORTED AS: UPON USE OF CAPIO DEVICE, THE NEEDLE TIP WAS MISSING. X-RAY ORDERED AND TIP NOTED TO BE IMBEDDED IN SUPRASPINOUS LIGAMENT. THE DECISION WAS MADE TO LEAVE THE TIP IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE DEVICE SUTURE DEVICE MFJ TELEFLEX MEDICAL 75925

    Patients

    Seq Age Sex Outcome Treatment
    1