BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH SOFRADIM - UGYTEX¿

    MDR report key: 8111479 · Received November 28, 2018

    Report

    Report Number
    9615742-2018-02629
    Event Type
    Death
    Date Received
    November 28, 2018
    Report Date
    November 28, 2018
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA ON AN ALTERNATIVE SUMMARY REPORT (ASR APPROVAL #: (B)(4), 05-31-2016) AND IS NOW BEING SUBMITTED ON A 3500A FORM BECAUSE OF NEWLY RECEIVED INFORMATION THAT THE PATIENT IS NOW DECEASED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SURGICAL INTERVENTIONS PER MEDICAL RECORDS FOR COMPLETE PROCIDENTIA, INTRINSIC SPHINCTER DEFICIENCY, OCCULT STRESS URINARY INCONTINENCE, PAIN, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA AFTER IMPLANTATION, SEVERE ANTERIOR WALL PROLAPSE, MODERATE ATROPHY, VAGINAL CUFF PROLAPSE, LEFT POSTERIOR WALL PROLAPSE, SIGNIFICANT DISCOMFORT, EMBARRASSMENT, CONFINED TO HOUSE, DEPRESSION, ANXIETY, AND POSSIBLE POST-TRAUMATIC STRESS DISORDER CONCERNING HER SURGERY, OCCULT STRESS URINARY INCONTINENCE, RECURRENT VAGINAL VAULT PROLAPSE, ANTERIOR REPAIR WITH GYNECARE PROLIFT, PARAVAGINAL SUSPENSION WITH GYNECARE PROLIFT, SACROSPINOUS VAGINAL VAULT SUSPENSION, GYNECARE TENSION FREE VAGINAL TAPE, FOLLOWED BY POSTOPERATIVE INCONTINENCE, ECCHYMOSIS OF THE BILATERAL LABIA MAJORA, DETRUSOR INSTABILITY, ANEMIA, PELVIC HEMATOMA, LARGE UMBILICAL HERNIA, URINARY LEAKAGE REQUIRING DIAPERS, URINARY RETENTION AND BLADDER DISTENTION REQUIRING FOLEY CATHETER PLACEMENT AND ANTIBIOTICS, OVERFLOW INCONTINENCE, URODYNAMIC TESTING, INTRINSIC SPHINCTER DEFICIENCY, DIAGNOSTIC CYSTOSCOPIES, REPEAT GYNECARE TENSION FREE VAGINAL TAPE PLACEMENT, RECURRENT URINARY TRACT INFECTIONS, URGENCY, FREQUENCY, AND URGE INCONTINENCE. THE PATIENT HAS REQUIRED MULTIPLE SURGICAL AND NON-SURGICAL INTERVENTIONS. THE PATIENT ALSO ALLEGED SHE EXPERIENCED REMOVAL OF MESH, PAIN AND DYSPAREUNIA. THE PATIENT IS NOW DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952066 MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UGY1510 P24209G3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death