BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 2216502 · Received August 18, 2011

    Report

    Report Number
    2210968-2011-01151
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. TENSION FREE VAGINAL TAPE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESHES WERE IMPLANTED DUE TO SYMPTOMATIC UTERINE PROLAPSE, CYSTOCELE, RECTOCELE AND URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING AND OTHER UNSPECIFIED ISSUES. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLANT SURGERY ON 7/18/09 DUE TO MESH EROSION, ANTERIOR AND POSTERIOR COLPORRHAPHY. THERE ARE TWO POSSIBLE DEVICES ASSOCIATED WITH THIS EVENT. THEY ARE AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT: PFRT01, LOT: 3070747, EXPIRATION DATE: 08/31/2010, MANUFACTURE DATE: 08/06/2007, APPROXIMATE AGE OF DEVICE: 11 MONTH, (B)(4). TENSION FREE VAGINAL TAPE: PRODUCT: 810081, LOT: 3128458, EXPIRATION DATE: 02/28/2009, MANUFACTURE DATE: 04/02/2008, APPROXIMATE AGE OF DEVICE: 3 MONTH, (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXPLANT ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2008 AND PELVIC FLOOR MESH AND A SLING WERE IMPLANTED. 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 51 YR