BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3172601 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-06844
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K063532
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL EXTRAPERITONEAL VAGINAL VAULT SUSPENSION AND PLATELET GRAFTING DUE TO MIDLINE AND LATERAL CYSTOCELE AND VAGINAL VAULT PROLAPSE.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/30/2013. 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). IT WAS REPORTED THAT THE FOLLOWING PROCEDURE THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT ANTERIOR COLPORRHAPHY WITH INTERPOSITION OF MESH.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT ANTERIOR COLPORRHAPHY WITH INTERPOSITION OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273404 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3403906

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention