BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX POS

    MDR report key: 3984591 · Received July 29, 2014

    Report

    Report Number
    2125050-2014-00386
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    January 9, 2012
    Report Date
    July 28, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAG
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE DIRECTFIX POS MESH. LATER THE PATIENT EXPERIENCED VAGINAL AND PELVIC PAIN, DISCHARGE, DYSURIA, URGENCY, FREQUENCY, MIXED INCONTINENCE, NOCTURIA, SPLINTING WITH BOWEL MOVEMENT, MESH EXPOSURE AND EXTRUSION, STRESS URINARY INCONTINENCE, BLADDER SPASMS, FOUL SMELLING URINE, CHANGE IN URINE COLOR, CRAMPING, VAGINAL FOREIGN BODY, DISCOMFORT, URINARY TRACT INFECTIONS, DYSPAREUNIA, URINARY RETENTION, HESITANCY, RECTAL INCONTINENCE AND PATIENT ALLEGES SPOUSE CAN FEEL AND WAS CUT BY MATERIAL DURING INTERCOURSE. ANTICHOLINERGICS, ANTIBIOTICS, ANALGESICS, ESTROGEN, PYRIDIUM AND ANTIFUNGALS WERE PRESCRIBED. AN EXCISION OF THE MESH WITH RECTAL SPHINCTEROPLASTY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441833 RESTORELLE DIRECTFIX POS SURGICAL MESH PAG COLOPLAST A/S 5014601400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other