BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGI-WRAP

    MDR report key: 2923318 · Received November 13, 2006

    Report

    Report Number
    2923318
    Event Type
    Injury
    Date Received
    November 13, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 9, 2006
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD LAPAROSCOPIC HYSTERECTOMY IN (B)(6) 2006. SURGI-WRAP WAS PLACED TO PREVENT ADHESIONS. THIS EMBEDDED INTO THE VAGINA AND LACERATED HER PARTNER. THIS WAS REMOVED ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGI-WRAP NONE FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization