BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2831543 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07155
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. ON (B)(6) 2010, THE PATIENT UNDERWENT MESH EXCISION DUE TO MESH EROSION AND URINARY INCONTINENCE. ON (B)(6) 2011, THE PATIENT UNDERWENT EXCISION OF SPARC DUE TO SEVERE INCONTINENCE AND MESH EROSION. ON (B)(6) 2011, THE PATIENT UNDERWENT EXCISION AND REVISION DUE TO MESH EROSION AND URINARY INCONTINENCE. (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.

    Additional Manufacturer Narrative · 1

    (B)(4): AT THE TIME OF MESH INSERTION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF ANTERIOR REPAIR, POSTERIOR REPAIR WITH MESH, VAGINAL VAULT SUSPENSION WITH MESH, ENTEROCELE REPAIR WITH MESH, CYSTOSCOPY, URETHRAL DILATATION AND SPARC SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. 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 3419393

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention