BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8913209 · Received August 20, 2019

    Report

    Report Number
    1645337-2019-17518
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    May 1, 2016
    Report Date
    July 2, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000570
    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

    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

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 700CC, CATALOG NUMBER: 3507004BC, SERIAL NUMBER: (B)(4), LOT NUMBER: 6813529. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S ASR EXEMPTION # E1999017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND EXPERIENCED BREAST PAIN AND RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705002 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507004BC 6813529 00081317000570

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention