BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 8685454 · Received June 10, 2019

    Report

    Report Number
    1645337-2019-13585
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/26/2019. THE DEVICE WAS DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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: MATERIAL RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE HAD AN UNKNOWN MENTOR SALINE PROSTHESIS PLACED FOR AN UNKNOWN INDICATION AND EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICAL EXAMINATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478189 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention