BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 3952008 · Received July 15, 2014

    Report

    Report Number
    9615742-2014-00224
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 5, 2009
    Report Date
    April 4, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 03/2/2015.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Description of Event or Problem · 1

    PER MEDICAL RECORD FINDINGS, THE PATIENT EXPERIENCED PAIN, INFECTION, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWEL PROBLEMS, RECURRENCE, AND DYSPAREUNIA.

    Description of Event or Problem · 1

    (B)(6) 2009 - MINIMAL VAGINAL BLEEDING - NORMAL POST OPERATIVE CHECK, SMALL RECURRENT CYSTOCELE - VAGIFEM TWICE WEEKLY FOR VAGINAL STRENGTH (INTERIM MEDICAL RECORDS FOR THE TIME PERIOD (B)(6) 2009-(B)(6) 2011 ARE NOT AVAILABLE FOR REVIEW). (B)(6) 2011 - SEVERE URINE LEAKAGE WITH URGE AND URINARY FREQUENCY FOR THE LAST 6 MONTHS, ABDOMINAL BLOATING, OVARIAN CYSTS, DIARRHEA AND CONSTIPATION THAT ALTERNATES - OVERACTIVE BLADDER, SMALL RECURRENT CYSTOCELE, OVARIAN CYSTS, ABDOMINAL BLOATING - RELATED TO OVARIAN CYST OR BOWEL - URINE CULTURE ORDERED - SCHEDULED FOR CYSTOSCOPY TO RULE OUT MESH EROSION. (URINE CULTURE AND CYSTOSCOPY REPORTS UNAVAILABLE). (FURTHER MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, MESH REVISION SURGERY: (B)(6) 2016 UNDERWENT TRANSVAGINAL EXCISION OF ERODED VAGINAL MESH, CYSTOCELE, RECTOCELE, AND ENTEROCELE REPAIR, KELLY-KENNEDY PLICATION OF THE BLADDER NECK, CYSTOSCOPY FOR CYSTOCELE, RECTOCELE, ENTEROCELE, VAGINAL MESH EROSION, URINARY FREQUENCY UNDER GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE REASON FOR MESH IMPLANTATION WAS A VAGINAL VAULT PROLAPSE, GENUINE STRESS INCONTINENCE WITH PROLAPSE REDUCTION. THE PROCEDURES PERFORMED INCLUDED A ROBOTIC ABDOMINAL COLPOSACROPEXY, SUBURETHRAL SLING AND CYSTOSCOPY. THE CONCOMITANT THERAPY WAS THE LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM. PER MEDICAL RECORD FINDINGS, THE PATIENT EXPERIENCED PAIN, INFECTION, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWEL PROBLEMS, RECURRENCE, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412938 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other