BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGRESS

    MDR report key: 2250006 · Received September 12, 2011

    Report

    Report Number
    MW5022239
    Event Type
    Other
    Date Received
    September 12, 2011
    Date of Event
    September 10, 2005
    Report Date
    September 12, 2011
    Manufacturer
    UNK
    Product Code
    FBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER WAS ABOUT (B)(6) WHEN HER UROLOGIST RECOMMENDED A TEGRESS IMPLANT. HE RECOMMENDED IT FOR URINARY INCONTINENCE. I FOUND OUT AFTERWARDS IT WAS NOT DESIGNED FOR CHILDREN WITH NEUROGENIC BLADDER AND IT HAS BEEN PULLED FROM MARKET. SHE HAS SYMPTOMS OF HEADACHE RAPID HEARTBEAT AND FEELINGS OF WEAKNESS THAT I SUSPECT COULD BE FROM PRODUCT LEACHING INTO HER BLOOD STREAM. IN SPITE OF CHECKED BOX ABOVE - NO DEATH. I HAD TO CHECK THE DEATH BOX ABOVE IN ORDER TO PROCEED - WHEN I CONTACTED THE TEL NUMBER ASSOCIATED WITH REPORTING THE PERSON ON THE HELP DESK SAID THERE IS A PROBLEM WITH THE BROWSER. I ALSO HAD TO CHECK MULTIPLE BOXES THAT WERE NOT RELEVANT. DATES OF USE: (B)(6) 2005 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGRESS UNKNOWN FBK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other