BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9907984 · Received March 31, 2020

    Report

    Report Number
    1645337-2020-05122
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    January 1, 2020
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317000525
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED ON APRIL 28, 2020, 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. THE IMPLANT DATE HAS BEEN ESTIMATED BASED ON THE MANUFACTURED DATE PROVIDED. D6 HAS BEEN UPDATED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 MENTOR RECEIVED THE IMPACTED PRODUCT. THE LOT NUMBER HAS BEEN UPDATED BASED ON THE DEVICE RECEIVED. THE UPDATED LOT NUMBER IS 6978370. MENTOR BECAME AWARE THAT THE COMPLAINT DEVICE REPORTED HEREIN WAS MANUFACTURED 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 (B)(6) 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. HOWEVER, IF [MENTOR BECOMES] AWARE OF INFORMATION THAT REASONABLY SUGGESTS A DEVICE HAS MALFUNCTIONED AND THAT A SIMILAR DEVICE THAT [IS] MARKETED IN THE US WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, THEN [MENTOR] SHOULD REPORT THE DEVICE MALFUNCTION THAT OCCURRED OUTSIDE THE US." MENTOR MEDICAL SYSTEMS B.V. DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, AND DO NOT MEET THE CRITERIA FOR REPORTING AS A SAME OR SIMILAR DEVICE, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. AS A RESULT, NO FURTHER SUPPLEMENTAL REPORTING WILL BE DONE FOR THIS EVENT. 1. MANUFACTURER SITE PHONE (B)(6) 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 WHO UNDERWENT BREAST AUGMENTATION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT ON AN UNKNOWN DATE EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. AS A RESULT, BILATERAL IMPLANT REPLACEMENT ON AN UNKNOWN DATE WAS PERFORMED. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. IF ADDITIONAL DETAILS ARE MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366035 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 3504504BC 6978370 00081317000525

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention