BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM CAPIO SUTURES

    MDR report key: 2043502 · Received February 25, 2011

    Report

    Report Number
    3004365956-2011-00092
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 4, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE AVAILABLE FOR EVAL BY MFR. DUE TO UNK LOT NUMBER AND UNK CATALOG NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE COMPLAINT COULD NOT BE CONFIRMED DUE TO LACK OF INFO AND DEFECTIVE SAMPLES. IF ADDITIONAL INFO ON THIS COMPLAINT IS RECEIVED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING THE PROCEDURE, THE CAPIO DEVICE TORE THE BULLET OFF OF THE SUTURE INSIDE THE PT. THE PHYSICIAN REMOVED THE SUTURE AND THE CAPIO WITH THE BULLET AND COMPLETED THE PROCEDURE WITH ANOTHER OF EACH DEVICE WITH NO PT COMPLICATIONS AND THE PT IS FINE. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR