BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 5386704 · Received January 22, 2016

    Report

    Report Number
    9615742-2016-00003
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 18, 2013
    Report Date
    February 1, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKING NUMBER: (B)(4). EXEMPTION NUMBER: 2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). F2: (B)(4). F5: +1(800)526-4455. BARD'S TRACKING NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKING NUMBER: (B)(4). EXEMPTION NUMBER: 2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). F2: (B)(4). F5: +1(800)526-4455 BARD'S TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED UNSPECIFIED MESH COMPLICATION, MESH IN POSTERIOR WALL OF VAGINA, MESH EXPOSURE, PAIN, EROSION, INFECTION, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, CONSTIPATION, SUPRAPUBIC PAIN, LOWER BACK PAIN, FREQUENCY, URGENCY, DYSURIA, RECTOCELE (PROLAPSE), RECTAL/VAGINAL BULGE, POST-DEFECATORY FULLNESS, VAGINAL TENDERNESS, NOCTURIA, STRESS/URGE INCONTINENCE, DRY SKIN AT LABIA, VAGINAL FOREIGN BODY (FOREIGN BODY IN PATIENT), URINARY TRACT INFECTION, BLADDER INFECTION, VAGINAL ATROPHY, SUTURE REMNANTS REMOVED, VAGINAL EPITHELIAL/POSTERIOR COMPARTMENT DEFECT, BLADDER TRABECULATIONS, ADHESIONS, OVERACTIVE BLADDER, UNSPECIFIED ABNORMAL VAGINAL CULTURES, IRRITATIVE BLADDER SYMPTOMS, DISCOMFORT, VULVAR/VAGINAL IRRITATION, DISCHARGE, ESCHERICHIA COLI/GROUP B STREPTOCOCCUS/BACTEROIDES IN VAGINAL CULTURE (BACTERIAL INFECTION), VAGINAL PAIN, PURITIC RASH, STINGING/BURNING IN VULVAR/PERINEAL AREA, VAGINAL INTROITIS TENDERNESS/REDNESS, VULVOVAGINITIS/VAGINITIS, BLOOD LOSS, VOIDING DYSFUNCTION, NON-SURGICAL INTERVENTION AND ADDITIONAL SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44166 PARIETEX UGYTEX PP 15X10CM X1 MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION UGY1510

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other