BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARRINGTON ROD

    MDR report key: 6136192 · Received November 29, 2016

    Report

    Report Number
    MW5066425
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    May 1, 2015
    Report Date
    November 29, 2016
    Manufacturer
    UNK07/01/1978
    Product Code
    PGM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEUROGENIC BLADDER. HARRINGTON ROD IMPLANTED (B)(6) 1978. (B)(6) 2015, I HAD A CT SCAN FOR POSSIBLE OVARIAN CANCER, THE ROD WAS DISCOVERED BROKEN AT THIS TIME. PRIOR TO THAT, I BEGAN HAVING PAIN, NUMBNESS AND WEAKNESS DOWN THE LEFT LEG ALONG WITH BLADDER INCONTINENCE. I AM A (B)(6) FEMALE NOW. I'M A NURSE AND UNABLE TO PERFORM MY JOB AT THE HIGH LEVEL I COULD PREVIOUSLY DUE TO PAIN AND NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784341 HARRINGTON ROD HARRINGTON ROD PGM UNK07/01/1978

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R