BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 8228653 · Received January 8, 2019

    Report

    Report Number
    1645337-2019-07823
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A 62 YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A GEL MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED GEL BLEED ON THE LEFT BREAST IMPLANT. THE PHYSICIAN OBSERVED A LARGE AMOUNT OF GEL BLEED ON THE LEFT IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL IMPLANTS, CATALOG # 3501501BC, S/NS (B)(4) (L) AND (B)(4) (R) ON (B)(6) 2018. THE DEVICE WAS RETURNED TO MENTOR WITH GEL THAT APPEARED TO BE CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. THE MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.7 CM ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. IT IS NOT POSSIBLE TO IDENTIFY A MICROSCOPIC LEAKAGE SINCE THE DEVICE WAS RENTED AND COVERED IN GEL. COMPLAINT WAS NOT CONFIRMED. GEL BLEED IS INHERENT IN THE USE, DESIGN AND/OR MATERIALS SPECIFIED FOR THESE DEVICES AND ARE REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A GEL MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED GEL BLEED ON THE LEFT BREAST IMPLANT. THE PHYSICIAN OBSERVED A LARGE AMOUNT OF GEL BLEED ON THE LEFT IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL IMPLANTS, CATALOG # 3501501BC, (B)(6) ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21466 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention