BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR IMPLANT

    MDR report key: 1711533 · Received May 27, 2010

    Report

    Report Number
    MW5016185
    Event Type
    Other
    Date Received
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION (B) (4), WE WISH TO INFORM YOU OF AN ADVERSE EVENT REPORT ASSOCIATED WITH ANOTHER MFR'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. ((B) (4)). THE FOLLOWING INFO WAS PROVIDED. PT'S DATE OF BIRTH: (B) (6). IMPLANT PHYSICIAN: NO INFO. EXPLANT PHYSICIAN: DR. (B) (6). ALLEGED EVENT: ALLERGAN'S DEVICE ANALYSIS LAB RECEIVED A RIGHT SIDE DEFLATED MENTOR IMPLANT. IMPLANT DATE: (B) (6) 2000. EXPLANT DATE: (B) (6) 2010. IF I MAY BE OF ANY FURTHER ASSISTANCE IN THIS MATTER, (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR IMPLANT NONE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1