BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 10305270 · Received July 21, 2020

    Report

    Report Number
    1645337-2020-08965
    Event Type
    Injury
    Date Received
    July 21, 2020
    Report Date
    June 29, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: MATERIAL RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS ON AN UNSPECIFIED SIDE, SUFFERED BREAST IMPLANT DEFLATION POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION AND REPLACEMENT IN 2013 WITH THE FOLLOWING DEVICES: (LEFT) 375CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE CATALOG: 3542660 LOT: 6597657 SN: (B)(4) AND (RIGHT) 375CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE CATALOG: 3542660 LOT: 5932027 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766595 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention