BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3973000 · Received August 1, 2014

    Report

    Report Number
    2210968-2014-10531
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESHES WERE IMPLANTED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 01/28/2016. (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009, AND A MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, DUE TO SUI, CYSTOCELE, AND URINARY RETENTION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2013, DUE TO EXTRUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. 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
    450103 GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3342494

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention