BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 QUICK-T

    MDR report key: 1012878 · Received March 12, 2008

    Report

    Report Number
    1219602-2008-00056
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    February 11, 2008
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIV.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE ANCHOR REMAINED EMBEDDED IN THE PT DURING THE PROCEDURE AND ANOTHER ANCHOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 QUICK-T TWINFIX QUICK-T MBI SMITH & NEPHEW INC. ENDOSCOPY DIV. 72200767 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1