BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 8784454 · Received July 12, 2019

    Report

    Report Number
    1645337-2019-15239
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    February 22, 2010
    Report Date
    June 19, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MW5087067 THAT A FEMALE PATIENT WITH UNKNOWN AGE, AND RACE UNDERWENT UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN SIZE UNKNOWN SALINE IMPLANT AND WAS PRESENTED WITH RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND GENERALIZED ILLNESS (BREAST IMPLANT ILLNESS LIKE DAILY FLU). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578132 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other