BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3173702 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-10270
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    September 7, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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). 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).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, DYSPAREUNIA, OVERACTIVE BLADDER AND URINARY FREQUENCY. IT WAS REPORTED THAT PATIENT UNDERWENT LYSIS OF ADHESIONS, CYSTOSCOPY, RIGHT SALPINGO-OOPHORECTOMY AND LEFT OVARIAN CYSTECTOMY ON (B)(6) 2010 AT (B)(6) HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND THE SOLYX SIS SYSTEM WERE 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
    273757 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3417654

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention