BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND HIGH PROFILE

    MDR report key: 11423908 · Received March 5, 2021

    Report

    Report Number
    1645337-2021-02359
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    December 20, 2020
    Report Date
    February 9, 2021
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAR 17 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. MENTOR IDENTIFIED THAT THE COMPLAINT DEVICE WAS MANUFACTURED AT THE MENTOR MEDICAL SYSTEMS B.V. FACILITY IN LEIDEN, THE NETHERLANDS. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. IT IS A SEPARATE LEGAL ENTITY FROM MENTOR TEXAS. PER 21 CFR 803.58 AND "MEDICAL DEVICE REPORTING FOR MANUFACTURERS" (FDA GUIDANCE DOCUMENT ISSUED ON NOVEMBER 8, 2016), WE ARE ¿[NOT] REQUIRED TO SUBMIT MDR REPORTS FOR EVENTS OCCURRING IN OTHER COUNTRIES FOR A DEVICE THAT IS MANUFACTURED IN A FOREIGN COUNTRY AND THAT IS NOT CLEARED OR APPROVED FOR MARKETING IN THE US." NO FURTHER REPORTS WILL BE SENT FOR THIS DEVICE. (B)(4). 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: CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (UNKNOWN SIDES) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III AND DEVICE RUPTURE (SIDE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE UNKNOWN DEVICE (NON-RUPTURED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321438 SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 6465445

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention