BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2242023 · Received September 9, 2011

    Report

    Report Number
    2210968-2011-01271
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 17, 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): 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: UNKNOWN. GYNECARE TVT SECUR SYSTEM, PRODUCT CODE: TVTS1, BATCH 3030032, MFG DATE: 06/26/2007, EXP DATE: 04/30/2009. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE TVTS BATCH WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT HAD A MESH REMOVAL SURGERY ON (B)(6) 2011. (B)(6). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, PRODUCT CODE: PFRT01, BATCH 3027761, MFG DATE: 05/14/2007, EXP DATE: 03/31/2010. GYNECARE TVT SECUR SYSTEM, PRODUCT CODE: TVTS1, BATCH 3030032, MFG DATE: 06/26/2007, EXP DATE: 04/30/2009. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AT THE TIME OF MESH IMPLANTATION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF VAGINAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY.

    Description of Event or Problem · 1

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