BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.R. BARD ALYTE Y MESH POLYPROPLENE

    MDR report key: 3893855 · Received June 19, 2014

    Report

    Report Number
    MW5036790
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    August 6, 2012
    Report Date
    June 18, 2014
    Manufacturer
    C.R. BARD
    Product Code
    OTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD BARD Y-MESH IMPLANTED FOR A PELVIC ORGAN PROLAPSE. SINCE THAT DATE, I HAVE HAD URINARY RETENTION. I HAD TO BE SHOWN HOW TO SELF-CATHERIZE. I HAVE HAD VAGINAL PAIN, ABDOMINAL PAIN, PAIN WITH INTERCOURSE, LOW BACK PAIN, BLEEDING AND GENERAL FEELING OF FATIGUE. CHRONIC INFLAMMATION AND CHRONIC ABDOMINAL AND LOW BACK PAIN, VAGINAL PAIN/PRESSURE, BLEEDING, URINARY RETENTION (I HAVE TO SELF-CATHERIZE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362122 C.R. BARD ALYTE Y MESH POLYPROPLENE C.R. BARD ALYTE Y MESH POLYPROPLENE OTO C.R. BARD Y500 HUWD1008

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| S IMITREX| VIT B12 INJECTIONS| PROBIOTIC| CITRACEL| VIT D| FIROICET| NEURONTIN| KONOPIN| ZANAFLEX| MAGNESIUM| VICODIN