BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2970308 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01477
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO CYSTOCELE AND RECTOCELE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED MESH EROSION, EXPOSURE, PAIN DURING INTERCOURSE, BLEEDING, URINARY INCONTINENCE AND URINARY TRACT INFECTIONS/BLADDER INFECTIONS. IT WAS REPORTED THAT DUE TO EXPOSED VAGINAL MESH/EROSION, PELVIC PAIN, DYSPAREUNIA AND BLEEDING THE PATIENT UNDERWENT EXCISION OF GRANULOMA, VAGINAL MESH AND GRANULATION TISSUE, DIAGNOSTIC CYSTOSCOPY AND REPAIR OF MESH ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, THE PATIENT 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
    73250 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3051270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention