BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11750278 · Received April 29, 2021

    Report

    Report Number
    1645337-2021-04761
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    August 1, 2018
    Report Date
    April 7, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, MENTOR BECAME AWARE THAT IMPACTED DEVICE IS A 450CC MENTOR MEMORYGEL BREAST IMPLANT. CATALOG: 3507450BC. LOT NUMBER 5990668. SERIAL NUMBER (B)(6). IMPLANTATION DATE IS UPDATED FROM (B)(6) 2008 TO AUG/3/2010. PATIENT ALSO EXPERIENCED RUPTURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. 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 AND CAPSULAR CONTRACTURE BAKER GRADE III MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 06-MAY-2021, MENTOR BECAME AWARE OF INCORRECT INFORMATION IN THE INITIAL REPORT. THE REPORT HAS BEEN CORRECTED ACCORDINGLY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). E1. INITIAL REPORTER STATE: (B)(6). G4. PMA/ 510(K): UNK.

    Additional Manufacturer Narrative · 0

    ON JANUARY 27, 2022, MENTOR BECAME AWARE THAT PATIENT DID NOT EXPERIENCE RUPTURE. PATIENT'S DEVICE WAS DISCARDED. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: SUSPECTED RUPTURE. MANUFACTURER¿S REFERENCE NUMBER:(B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. 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 CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH UNKNOWN 350CC MENTOR GEL BREAST IMPLANT EXPERIENCED LEFT-SIDED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. CAPSULAR CONTRACTURE WAS DIAGNOSED BY PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641373 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5990668

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other| R