BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3881112 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07788
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR/POSTERIOR REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A VAGINAL MESH EROSION. THE PATIENT UNDERWENT A MESH EXCISION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358678 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3475449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention