BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT CB PLUG KITS

    MDR report key: 1961799 · Received January 14, 2011

    Report

    Report Number
    1219602-2011-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    SURGEON REPORTED THAT A PATIENT HAD SURGERY WITH TRUFIT PLUG AND POST-OPERATIVELY SHOWS SOFTNESS OF THE PLUGS AT 15 MONTHS POST-OP. PATIENT WAS MANAGED FOR SYMPTOMS. PATIENT OUTCOMES WERE BAD AT 12 MONTHS BUT IMPROVED SIGNIFICANTLY AT 24 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT CB PLUG KITS TRUFIT CB PLUG, GREEN, 5MM MQV SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72200930 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR