BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2113109 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00702
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 10, 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

    THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: GYNECARE GYNEMESH PS, PRODUCT CODE NI, BATCH NI, EXP DATE NI, MFG DATE NI. TENSION FREE VAGINAL TAPE, PRODUCT CODE 810081, BATCH 3182104, EXP DATE 06/30/2009, MFG DATE 07/29/2008, IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (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: GYNECARE GYNEMESH* PS TENSION FREE VAGINAL TAPE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A MCCALL CULDOPLASTY, PERINEOPLASTY, POSTERIOR PERINEORRHAPHY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, DYSPAREUNIA, DEPRESSION. PATIENT HAD COLONOSCOPY WITH ILEOSTOMY FOR CANCER SCREENING ON (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS 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 51 YR Required Intervention