BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 8663372 · Received June 3, 2019

    Report

    Report Number
    1645337-2019-13098
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    May 6, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: NO REOPERATION OR EXPLANT WAS PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD UNKNOWN MENTOR SALINE PROSTHESES PLACED EXPERIENCED ILLNESS, SEVERAL UNSPECIFIED MEDICAL PROBLEMS, AND ELEVATED ANTINUCLEAR ANTIBODIES POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. SEE 1645337-2019-13097 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455137 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other