BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 6541225 · Received May 1, 2017

    Report

    Report Number
    MW5069537
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    February 10, 2012
    Report Date
    May 1, 2017
    Manufacturer
    MT GMD UNIVERSAL SLING, GENERIC MEDICAL DEVICES
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE NO CONTROL OVER MY BLADDER. I HAD TO HAVE ANOTHER SURGERY TO PUT A INTERSTIM IMPLANTED IN MY LEFT BUT CHEEK. STOMACH CRAMPS, BLADDER INFECTION, PAIN WITH SEX, DISCOMFORT. LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315477 TRANSVAGINAL MESH TRANSVAGINAL MESH FTL MT GMD UNIVERSAL SLING, GENERIC MEDICAL DEVICES NONE 23566J10

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability ESTRADIOL| FIORICET| FLEXSEED| GABAPENTIN| HYDROXYCHLOR | LISINOPRIL| NIFEDICAL XL| PILOCARPINE| PREDNISONE | PROGESTERONE| RESTASIS | TRAMADOL| TRAZODONE| VITAMIN D