BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROFIX FASTENER SYSTEM

    MDR report key: 3715126 · Received March 31, 2014

    Report

    Report Number
    2210968-2014-04042
    Event Type
    Injury
    Date Received
    March 31, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    PBQ
    PMA / PMN Number
    K042603
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE FOR PELVIC FLOOR REPAIR AND REDUCTION OF AN ENTEROCELE IN (B)(6) 2007 AND FASTENERS WERE USED TO SECURE MESH. IN (B)(6) 2007, STITCH MATERIAL WAS PALPABLE IN THE VAGINAL WALL. THE PATIENT EXPERIENCED URINARY URGENCY, URGE INCONTINENCE, DIFFICULTY URINATING, AND PAIN IN THE LOWER ABDOMEN AND ON THE LEFT SIDE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192724 GYNECARE PROFIX FASTENER SYSTEM IMPLANTABLE STAPLE, NONABSORBABLE PBQ ETHICON INC. 2921031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention