BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10352854 · Received July 31, 2020

    Report

    Report Number
    1645337-2020-09466
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    August 28, 2019
    Report Date
    July 9, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003878
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON SEPTEMBER 23 2020; DURING THE VISUAL EVALUATION, THE DEVICE WAS OBSERVED TO BE RUPTURED. THE DEVICE WAS RECEIVED IN FOUR PIECES. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION/RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON AUGUST 31 2020 THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE 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. THE LOT NUMBER ON THE DEVICE IS 6855179. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL,750CC SILICONE PROSTHESIS ON THE LEFT SIDE, AND UNKNOWN MENTOR SILICONE PROSTHESIS ON THE RIGHT SIDE EXPERIENCED LEFT GEL BREAST IMPLANT RUPTURE DISCOVERED DURING REVISION SURGERY OF ASYMMETRY CORRECTION. IMPLANT WAS REPLACED WITH GEL MENTOR PROSTHESIS. ON RIGHT SIDE, A STRESS TEST WAS PERFORMED ON THE IMPLANT AND NO LEAKS OR RUPTURES WERE FOUND; THE IMPLANT WAS REINSERTED, THESE PROCEDURES PERFORMED ON (B)(6) 2019. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813580 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507504BC 6855179 00081317003878

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention