BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM CAPIO SUTURE

    MDR report key: 2052121 · Received March 1, 2011

    Report

    Report Number
    3004365956-2011-00086
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CONCLUSIONS: NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN. OTHER - THE CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN, THEREFORE, NO INVESTIGATION COULD BE PERFORMED AND NO CONCLUSION COULD BE DRAWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DEVICE FAILED DURING SURGERY. THE "BULLET" WAS LEFT IN THE PATIENT. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1