BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2772411 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06035
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, INFECTIONS, PAIN AND A STAGE 3 CYSTOCELE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF AN ANTERIOR VAGINAL REPAIR, REMOVAL OF PREVIOUS MESH, AND OPERATIVE CYSTOSCOPY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. THE PATIENT UNDERWENT CYSTOSCOPIC REMOVAL OF FOREIGN BODY MESH AND URETHROCYSTOSCOPY ON (B)(6) 2012 DUE TO URETHRAL MESH EROSION. THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY, VAGINAL VAULT SUSPENSION TO HIGH UTEROSACRAL LIGAMENT BILATERALLY, REMOVAL OF FOREIGN BODY MESH FROM THE ANTERIOR SEGMENT OF THE VAGINA, ANTERIOR AND POSTERIOR REPAIR, SUBURETHRAL SLING (MONARC), AND CYSTOSCOPY ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (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

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06032, 2210968-2012-06033, 2210968-2012-06034 AND 2210968-2012- 06036. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MORE MESH WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND ANOTHER MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT 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 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3374406

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention