BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8795478 · Received July 16, 2019

    Report

    Report Number
    1645337-2019-15438
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    December 1, 2018
    Report Date
    June 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000280
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/5/2019, IT WAS REPORTED TO MENTOR THAT THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8/5/2019, A PHOTO OF AN AFFECTED PRODUCT WAS RECEIVED FOR EVALUATION. ON 8/20/2019, UPON VISUAL INSPECTION OF THE PICTURE, IT WAS OBSERVED TO BE INTACT. THE PHOTOS DO NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR COULD NOT UNCOVER A DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS, HOWEVER COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED BY QUALITY ASSURANCE TO DETERMINE IF FURTHER ACTION IS NECESSARY. 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 (MRE) WAS PERFORMED, 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE AND LOCAL REACTION. CONCOMITANT PRODUCTS: A MENTOR MEMORYGEL BREAST IMPLANT 300CC , CATALOG 3503001BC, SN (B)(4), LOT 5953738. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC AND EXPERIENCED RUPTURE ON THE LEFT BREAST IMPLANT. ¿SHE EXPERIENCED SEVERE PAIN, SWELLING AND SOME KIND OF NOISE COMING FROM BREAST ¿. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587371 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5953738 00081317000280

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention