BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1711493 · Received May 27, 2010

    Report

    Report Number
    MW5016171
    Event Type
    Other
    Date Received
    May 27, 2010
    Report Date
    May 20, 2010
    Product Code
    FWM
    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 AT ALLERGAN INC. (B) (4). THE FOLLOWING INFO WAS PROVIDED: (B) (6). EXPLANT PHYSICIAN: DR. (B) (6). ALLEGED EVENT: DOCTOR REPORTED REPLACING LEFT SIDE DEVICE DUE TO CAPSULAR CONTRACTURE. MANUFACTURER OF THE DEVICE WAS NOT ALLERGAN MEDICAL. THERE IS NO COMPLAINT AGAINST AN ALLERGAN MEDICAL DEVICE. IMPLANT DATE: (B) (6) 1995. EXPLANT DATE: (B) (6) 2010. (B) (6)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1