BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMSH PS 4INX6IN

    MDR report key: 15765274 · Received November 9, 2022

    Report

    Report Number
    2210968-2022-09310
    Event Type
    Injury
    Date Received
    November 9, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    UDI-DI
    20705031037738
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON 11/19/2003 AND MESH X2 WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLETE WALL PROLAPSE, URGENCY, LOW BACK PAIN, HIP PAIN, ABDOMINAL PAIN, COCCYGEAL PAIN, URINE TRACT INFECTIONS, ULCERATED CYSTOCELE, DYSPAREUNIA, STRESS INCONTINENCE, FREQUENCY, NOCTURIA, VAGINAL DISCOMFORT, GROIN PAIN, BUTTOCK PAIN, CONSTIPATION, DYSURIA, URINARY LEAKAGE AND PELVIC PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649856 GYNECARE GYNEMSH PS 4INX6IN MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. GPSL SDEQ05 20705031037738

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention