BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2903742 · Received January 9, 2013

    Report

    Report Number
    2210968-2013-00186
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A RECURRENT CYSTOCELE AND URINARY RETENTION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EXPOSURE, DYSPAREUNIA AND UNDERWENT MESH REMOVAL ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2011 DUE TO EXPOSURE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12097 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3068750

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention