BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILEX

    MDR report key: 916703 · Received September 20, 2007

    Report

    Report Number
    1216677-2007-00025
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 20, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPLICATOR IS USED TO DELIVER TRIMO SAN INTO THE VAGINAL CAVITY. IT IS POSSIBLE A ROUGH EDGE MAY CAUSE A SLIGHT ABRASION TO THE VAGINAL WALL. ANY BLEEDING WOULD BE CONSIDERED MINOR AND SELF-CONTAINED. AS OF THIS REPORT, THE APPLICATOR HAS NOT BEEN RETURNED. VISUAL INSPECTION OF THE APPLICATOR WILL BE PERFORMED UPON ITS ARRIVAL.

    Description of Event or Problem · 1

    PATIENT CALLED COOPERSURGICAL CUSTOMER SERVICE CLAIMING THE APPLICATOR USED WITH TRIMO SAN HAD A ROUGH EDGE. AFTER USING THE APPLICATOR, SHE STARTED BLEEDING IMMEDIATELY. PATIENT WAS ADVISED TO SEE HER PHYSICIAN OR GO TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILEX APPLICATOR HHW COOPERSURGICAL, INC. MXAPP

    Patients

    Seq Age Sex Outcome Treatment
    1 YR