BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1711503 · Received May 28, 2010

    Report

    Report Number
    MW5016177
    Event Type
    Other
    Date Received
    May 28, 2010
    Report Date
    May 28, 2010
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT REPORT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AST ALLERGAN INC. (B) (4). THE FOLLOWING INFO WAS PROVIDED: (B) (6). IMPLANT PHYSICIAN: NO INFO. EXPLANT PHYSICIAN: DR. (B) (6). ALLEGED EVENT: PHYSICIAN REPORTED LEFT SIDE RUPTURE AND "SILICONE GRANULOMA" AGAINST A NON-ALLERGAN DEVICE. THERE IS NO COMPLAINT AGAINST AN ALLERGAN DEVICE. IMPLANT DATE: (B) (6) 1992. EXPLANT DATE: (B) (6) 2008. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FTR

    Patients

    Seq Age Sex Outcome Treatment
    1