BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 14196488 · Received April 25, 2022

    Report

    Report Number
    1645337-2022-04632
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000044
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APRIL 28, 2022, THE MENTOR ANALYSIS LAB RECEIVED THE SUSPECT MEDICAL DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON MAY 02, 2022, MENTOR BECAME AWARE THAT THE DEVICE LOT NUMBER, 190621, WAS INADVERTENTLY EXCLUDED FROM THE INITIAL REPORT. ADDITIONALLY, AN INCORRECT EXPIRATION DATE WAS POPULATED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). IN THE INITIAL, D4. LOT AND D4. EXPIRATION DATE SHOULD HAVE BEEN POPULATED WITH 190621 AND 4/30/2004, RESPECTIVELY.

    Additional Manufacturer Narrative · 0

    ON MAY 03, 2022, MENTOR COMPLETED A DEVICE EVALUATION ON THE RETURNED DEVICE. MENTOR CONDUCTED A VISUAL INSPECTION OF THE DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED. IN ADDITION, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE TEAR. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT AFTER AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 250CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953006 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507175BC 190621 00081317000044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention