BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFT DIVERTED TUBE (3/4 FILLED)

    MDR report key: 2210090 · Received August 3, 2011

    Report

    Report Number
    2249062-2011-00001
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MTF
    Product Code
    MBP
    PMA / PMN Number
    K060161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT SURGERY AND WAS IMPLANTED WITH 4 UNITS OF AFT. ON (B)(6) 2011, THE PT RETURNED TO THE OPERATING ROOM BECAUSE OF DRAINAGE AT THE INCISION SITE. CULTURES WERE OBTAINED; THE RESULTS ARE PENDING. THE PT HAS UNDERGONE TWO IRRIGATION AND DEBRIDEMENT (I & D) PROCEDURES. THE REPORTER COULD NOT CONFIRM RECORD OF ANTIBIOTIC TREATMENT. CURRENT STATUS OF THE PT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED; NOT YET RECEIVED. SEE MEDWATCH # 2249062-2011-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFT DIVERTED TUBE (3/4 FILLED) BONE VOID FILLER MBP MTF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization