BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2028706 · Received March 24, 2011

    Report

    Report Number
    2210968-2011-00345
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    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 GYNECARE TVT OBTURATOR

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES FOR MESH REMOVAL ON (B)(6) 2009; (B)(6) 2009; (B)(6) 2010 AND (B)(6) 2010. SHE UNDERWENT AN ENTEROCELE CLOSURE, UTEROSACRAL SUSPENSION, MCCALLS CUL-DE-PLASTY ON (B)(6) 2011. (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT CODE PFRA02, BATCH 3283421, GYNECARE TVT OBTURATOR : PRODUCT CODE 810081, BATCH 3222342.

    Additional Manufacturer Narrative · 1

    (B)(4) - THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT CODE PFRA02, BATCH 3283421, EXP DATE 12/31/2011, MFG DATE 01/16/2009. GYNECARE TVT OBTURATOR : PRODUCT CODE 810081, BATCH 3222342, EXP DATE 09/30/2009, MFG DATE 10/24/2008. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR REPAIR AND A SLING PROCEDURE ON (B)(6) 2009 AND MESH WAS 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 FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention