BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH TSL - PELVICOL¿

    MDR report key: 8768489 · Received July 8, 2019

    Report

    Report Number
    9617613-2019-00117
    Event Type
    Injury
    Date Received
    July 8, 2019
    Report Date
    July 8, 2019
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 OF VAULT PROLAPSE, LARGE CYSTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BLOOD LOSS, THIRD DEGREE CYSTOCELE, SECOND DEGREE RECTOCELE (PROLAPSE), SECOND TO THIRD DEGREE UTERINE PROLAPSE, ENDOMETRIAL LESION, EXTENSIVE SCARRING UNDER THE BLADDER (SCARRING), PELVIC ORGAN PROLAPSE PELVIC FLOOR PROLAPSE, CONTINUED URINARY INCONTINENCE, CONTINUED/INCREASED STRESS URINARY INCONTINENCE, MYOMAS X 2, HYPERMOBILE URETHRA, VERY THICKENED ANTERIOR VAGINAL WALL DUE TO THE GRAFT, UTERINE POLYPS, CONTINUOUS PAIN, DISCOMFORT, DRAINAGE, MENTAL AND PHYSICAL STRESS, VAGINAL VAULT DAMAGE, RECURRENCE, INFECTION, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWEL PROBLEMS, AS WELL AS UNSPECIFIED NEUROMUSCULAR PROBLEMS. THE DEVICE HAD BEEN USED WITH MENTOR OB/TAPE 93-4000 (LOT# 040702E). POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561223 MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC FTL TISSUE SCIENCE LABORATORIES 482812 04B23-9

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention