BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMO SAM

    MDR report key: 1402434 · Received June 15, 2009

    Report

    Report Number
    1216677-2009-00013
    Event Type
    Injury
    Date Received
    June 15, 2009
    Date of Event
    April 30, 2009
    Report Date
    June 15, 2009
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT DATABASE DID NOT INDICATED ANY PREVIOUSLY REPORTED ALLERGIC REACTIONS TO TRIMO SAN. THE PATIENT IS SAID TO BE A FIRST TIME WEARER. THE PATIENT MAY BE ALLERGIC TO SILICONE. SILICONE ALLERGIES ARE RARE. THE INVESTIGATION IS CURRENTLY ON GOING. THIS REPORT WILL BE SUPPLEMENTED AS NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    PATIENT WAS FITTED FOR A PESSARY. PATIENT LATER DEVELOPED A RASH BELIEVED TO BE CAUSE BY THE TRIMO SAN GEL USED IN CONJUNCTION WITH THE PESSARY. THE PATIENT WAS GIVEN A MEDICATION FOR THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMO SAM GEL KMJ COOPERSURGICAL, INC. MX5030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention