BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3233569 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13637
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 9, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A ANTERIOR REPAIR. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    332980 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3483009

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention