BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9590467 · Received January 15, 2020

    Report

    Report Number
    1645337-2020-00860
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    October 1, 2019
    Report Date
    December 30, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000099
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS, RUPTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR MEMORYGEL SILICONE, 300 CC BREAST IMPLANTS WHICH THE PATIENT REPORTED THE RIGHT SIDE RUPTURED, WITH FATIGUE, CHEST PAIN, BRAIN FOG, LOW IMMUNE SYSTEM ALWAYS GETS SICK. PATIENT INDICATED THAT SHE HAD SEEN PHYSICIAN REGARDING THESE ISSUES AND THE DIAGNOSIS IS UNKNOWN AT THIS TIME. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52976 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507300BC 6417022 00081317000099

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention