BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM UNKNOWN

    MDR report key: 2771385 · Received September 26, 2012

    Report

    Report Number
    3004365956-2012-00288
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 11, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE A VALID LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE; THE MATERIAL AND LOT NUMBER WERE NOT PROVIDED TO PERFORM AN INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: INFORMATION WAS RECEIVED AT A CONFERENCE. PHYSICIAN DESCRIBED THAT THEY USED THE CAPIO DEVICE AND AFTER THEY HAD APPLIED THE SUTURE, THE CAPIO SUTURE NEEDLE SEPARATED FROM THE SUTURE. UNKNOWN IF THIS PIECE WAS LEFT IN PATIENT. NO ADDITIONAL EVENT INFORMATION WILL BE AVAILABLE. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1