BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1881049 · Received October 19, 2010

    Report

    Report Number
    2210968-2010-01333
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    September 26, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNSPECIFIED TREATMENT OF VOLEMIA. BLEEDING OCCURRED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ANTERIOR PELVIC FLOOR PROLAPSE PROCEDURE ON AN UNK DATE. DURING DISSECTION AND MESH PLACEMENT, DEEP PELVIC BLEEDING IN EXCESS OF 1000ML OCCURRED. THE BLEEDING SITE WAS REPAIRED WITH SUTURE AND THE PT REACHED HEMOSTASIS. THE PT WAS SENT TO THE INTENSIVE CARE UNIT FOR HYPOVOLEMIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention