BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATEL BL MF 0 TC-43 2N 48¿

    MDR report key: 2481206 · Received March 1, 2012

    Report

    Report Number
    3004365956-2012-00094
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) WAS PREVIOUSLY REVIEWED UNDER ANOTHER SIMILAR COMPLAINT. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. DHR SHOW THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME DUE TO THE LACK OF DEFECTIVE SAMPLE AND THAT THE DHR DOES NOT SHOW ANY ISSUES OR DISCREPANCIES WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. IF THE SAMPLE BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE SUTURE WAS BEING PLACED AT THE PELVIC FLOOR NEAR THE SACROSPINOUS LIGAMENT WHEN THE NEEDLE DETACHED. THE BREAK WAS AT THE NEEDLE. DURING A SACROSPINOUS FIXATION, THE BULLET CAME OFF THE SUTURE AND THE BULLET WAS LOST IN THE BODY. NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEKNATEL BL MF 0 TC-43 2N 48¿ SUTURE MFJ TELEFLEX MEDICAL 02F1003349

    Patients

    Seq Age Sex Outcome Treatment
    1