BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM CAPIO SUTURES

    MDR report key: 2062367 · Received March 18, 2011

    Report

    Report Number
    3004365956-2011-00116
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED TO MFR IN TIME FOR THIS REPORT. INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING THE PROCEDURE, THE NEEDLE DETACHED WHEN PASSING IT THROUGH THE SACROSPINOUS LIGAMENT. 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