BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2242064 · Received September 9, 2011

    Report

    Report Number
    2210968-2011-01273
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: (B)(4), BATCH 3146821, EXP DATE 04/30/2011; MFG DATE 05/06/2008. GYNECARE TVT OBTURATOR, PRODUCT: (B)(4), BATCH 3157239, EXP DATE 05/31/2009, MFG DATE 06/04/2008. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH HYSTERECTOMY. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION , THE PATIENT EXPERIENCED SEVERE PELVIC, ABDOMINAL VAGINAL PAIN, PAINFUL INTERCOURSE, VAGINAL INFECTIONS, VAGINAL ODOR, CHRONIC URINARY RETENTION, VAGINAL BLEEDING, RECURRENT URINARY INCONTINENCE, PAIN AND DISCOMFORT, VAGINAL PRESSURE AND INFLAMMATION, UNRELENTING PAIN AND INABILITY TO ENGAGE IN SEXUAL RELATIONS, DEPRESSION/ANXIETY DUE TO UNRELENTING PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM, PRODUCT CODE: PFRP01, BATCH (B)(4). GYNECARE TVT OBTURATOR, PRODUCT CODE: 810081, BATCH (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2008 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, MESH AND A SLING WERE PLACED INTO THE PATIENT'S BODY. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention