BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 6350721 · Received February 22, 2017

    Report

    Report Number
    1645337-2017-00011
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    January 27, 2017
    Report Date
    January 27, 2017
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 27, 2017, MENTOR WORLDWIDE LLC HAS INITIATED A VOLUNTARY REMEDIAL ACTION TO REMOVE ONE (1) LOT OF MENTOR® SALINE-FILLED SPECTRUM¿ BREAST IMPLANTS (575 CC) LOT NUMBER 7377332. SOME UNITS IN THE AFFECTED LOT DO NOT CONTAIN THE DOME PACK ACCESSORY INDICATED ON THE BOX LABEL. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. (B)(4). THE DEVICE WAS NOT RECEIVED BY MENTOR YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIAN NOTICED THE DOMES WERE MISSING IN MENTOR SALINE SMOOTH ROUND SPECTRUM IMPLANTS 575CC IMPLANTS (LOT # 7377332-010) DURING SURGERY. BY THAT TIME, THE PATIENT WAS ON THE TABLE. PHYSICIAN OPENED ANOTHER SET OF IMPLANTS (LOT # 7377332-033) HOWEVER IT WAS MISSING DOMES AS WELL. ADDITIONAL INFORMATION WAS OBTAINED: THE PROCEDURE WAS NOT CANCELED AS THE PHYSICIAN CONTINUED THE PROCEDURE. HOWEVER THE DELAY CAUSED A POTENTIAL RISK TO THE PATIENT. THE EVENT REQUIRED SURGICAL INTERVENTION AS THE PHYSICIAN USED A VENOUS PORTS SEAL KIT ON THE PATIENT. PATIENT WAS REQUIRED EXTENDED HOSPITALIZATION. PATIENT WAS UNDER GENERAL ANESTHESIA FOR 4 HOURS (FROM 7:46AM TO 12:06PM). THE PATIENT IS FINE NOW. NO OTHER INFORMATION WAS AVAILABLE ABOUT THE PATIENT. DEVICE WAS SENT BACK TO MENTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131206 BREAST IMPLANT FWM MENTOR WORLDWIDE LLC 7377332-010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R