BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11247987 · Received January 28, 2021

    Report

    Report Number
    1645337-2021-00777
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 5, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000570
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23-FEB-2021, MENTOR BECAME AWARE OF OMITTED INFORMATION IN THE INITIAL REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). LOT: 5863962; H4. DEVICE MANUFACTURING DATE: 31-OCT-2008; D4. EXPIRATION DATE: 30-OCT-2013. LOT: 5861664; H4. DEVICE MANUFACTURING DATE: 23-OCT-2008; D4. EXPIRATION DATE: 22-OCT-2013.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 FOR BOTH LOT NUMBERS PROVIDED, 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: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 700CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SLOSHING SOUND AND SUSPECTED IMPLANT RUPTURE POSTOPERATIVELY, ON AN UNKNOWN SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. BOTH LOT-SERIAL NUMBERS (B)(4) WERE PROVIDED, BUT IT IS UNKNOWN WHICH LOT-SERIAL NUMBER BELONGS TO THE IMPACTED SIDE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144325 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507004BC 00081317000570

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other