BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 4163469 · Received October 10, 2014

    Report

    Report Number
    2210968-2014-14442
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. SHORTLY AFTER THE SURGERY, THE PATIENT EXPERIENCED VARIOUS UNDESCRIBED COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639529 GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2993944

    Patients

    Seq Age Sex Outcome Treatment
    1 Other