BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2197511 · Received August 9, 2011

    Report

    Report Number
    2210968-2011-01088
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ETHICON
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY AND SURGERY FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE ON (B)(6) 2007 . DURING THE PROCEDURE, MESH AND A SLING WERE PLACED INTO THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL PROCEDURES IN NOVEMBER 2007 AND OCTOBER 2009, DUE TO PAIN, STRESS URINARY INCONTINENCE, DYSURIA, FECAL INCONTINENCE, DYSPAREUNIA AND EROSION.

    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 PELVIC FLOOR REPAIR PRODUCT CODE PFRT01, BATCH 2991719. TENSION FREE VAGINAL TAPE PRODUCT CODE 810061, BATCH 3016683.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT CODE PFRT01, (B)(4), EXP DATE 12/31/2012, MFG DATE 01/15/2007. TENSION FREE VAGINAL TAPE: PRODUCT CODE 810061, (B)(4), EXP DATE 02/29/2008, MFG DATE 03/21/2007. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, PELVIC FLOOR REPAIR MESH AND A SLING WERE USED. 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 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention