BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS SMOOTH

    MDR report key: 11345760 · Received February 18, 2021

    Report

    Report Number
    1645337-2021-01714
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    January 1, 2015
    Report Date
    January 28, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 19, 2021, MENTOR BECAME AWARE THAT THE PREVIOUSLY SUBMITTED REPORTS FOR THIS COMPLAINT WERE SUBMITTED IN ERROR. MENTOR TEXAS GEL DEVICES ARE NOT DISTRIBUTED IN COLOMBIA, THE COUNTRY OF IMPLANTATION. THESE ARE INSTEAD SUPPLIED BY MENTOR MEDICAL SYSTEMS B.V. 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. 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." SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, AND HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. SHOULD ADDITIONAL INFORMATION BE RECEIVED THAT CHANGES THE US FDA REPORTABILITY OF THE EVENT, A SUPPLEMENTAL WILL BE SUBMITTED. 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: NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH UNSPECIFIED MENTOR SMOOTH GEL IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, AS WELL AS GENERALIZED ILLNESS SYMPTOM INCLUDING HEADACHES AND FEVER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240129 UNKNOWN GEL IMPLANTS SMOOTH PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other