BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPG 323

    MDR report key: 12939633 · Received December 6, 2021

    Report

    Report Number
    1645337-2021-13399
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 16, 2021
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    P060028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 9, 2021, MENTOR RECEIVED THE LOT NUMBER FOR THE DEVICE IMPLANT. MENTOR DETERMINED THAT THE DEVICE WAS MANUFACTURED IN LEIDEN, 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. 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. AS A RESULT, NO FURTHER REPORTS WILL BE SENT. MANUFACTURER SITE PHONE: (B)(4). MANUFACTURER SITE FAX: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED MENTOR BREAST IMPLANT INTENDED FOR AN UNSPECIFIED BREAST SURGERY RUPTURED PREOPERATIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE TYPE OF DEVICE BEING REPORTED IS UNKNOWN. COMMON DEVICE NAME/PRODUCT CODE VALUES ARE BEING USED FOR SUBMISSION PURPOSES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833994 CPG 323 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 9441910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown