BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 9233475 · Received October 24, 2019

    Report

    Report Number
    1645337-2019-22477
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    August 31, 2019
    Report Date
    October 7, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (VIA FDA MEDWATCH MW5089550) THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN SIZE UNKNOWN SALINE IMPLANT ON BOTH SIDES DEVELOPED ALL KINDS OF UNEXPLAINED SYMPTOMS WITH SILICONE AND THEN SALINE MENTOR IMPLANTS. FATIGUE, INSOMNIA, CHRONIC MIGRAINES, CHRONIC JOINT/ MUSCLE PAIN, HEARING LOSS, TINNITUS, CHRONIC DRY EYE, ETC WERE REPORTED. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. 95% OF THE SYMPTOMS IMPROVED SIGNIFICANTLY AFTER THE EXPLANT. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE WITH UNKNOWN SALINE. RELATED FILES: MANUFACTURER REPORT NUMBER: 1645337-2019-22482 (RIGHT SIDE WITH UNKNOWN GEL). MANUFACTURER REPORT NUMBER: 1645337-2019-22480 (LEFT SIDE WITH UNKNOWN GEL). MANUFACTURER REPORT NUMBER: 1645337-2019-22438 (LEFT SIDE WITH UNKNOWN SALINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029019 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention