BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8552728 · Received April 25, 2019

    Report

    Report Number
    1645337-2019-10603
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    February 19, 2015
    Report Date
    March 27, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/30/2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS A MENTOR MEMORYGEL BREAST IMPLANT, CATALOG NUMBER 3507255MC, SERIAL NUMBER (B)(4), LOT NUMBER 6864109. THE CONCOMITANT PRODUCT WAS IDENTIFIED AS A MENTOR MEMORYGEL BREAST IMPLANT, CATALOG NUMBER 3507255MC, SERIAL NUMBER (B)(4), LOT NUMBER 6861898. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING CHRONIC HEADACHES, INTESTINAL ISSUES, JOINT PAIN, AND INFLAMMATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THE CAPSULES WERE SENT TO PATHOLOGY. THE DIAGNOSIS STATED, ¿BOTH THE RIGHT AND LEFT BREAST CAPSULE: FIBROUS CONNECTIVE TISSUE WITH PSEUDOSYNOVIAL METAPLASIA, COMPATIBLE WITH BREAST CAPSULE; FOCAL TRANSLUCENT FOREIGN MATERIAL WITH GIANT CELL REACTION.¿ NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346558 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6864109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention