BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2923838 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00449
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DYSPAREUNIA. 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 AND MESH WAS IMPLANTED DUE TO RECURRENT VAGINAL VAULT PROLAPSE AND URINARY URGE INCONTINENCE. THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE AND BLEEDING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT RECURRENT VAGINAL VAULT PROLAPSE AND URINARY URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF CORRECTION OF CYSTOCELE, RECTOCELE AND ENTEROCELE, VAGINAL VAULT COLPOPEXY, EXTENSIVE PERINEOPLASTY AND WATER CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS USED. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE, 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
    29521 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1332542

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention