BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9202072 · Received October 17, 2019

    Report

    Report Number
    1645337-2019-21935
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    January 1, 2017
    Report Date
    September 23, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 23RD, 2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THIS EVENT. DETAILS ABOUT THE PRODUCT WERE RECEIVED, ALONG WITH INFORMATION THAT THE DATE OF EXPLANT WAS MOVED FROM (B)(6) 2020 TO (B)(6) 2020. THE APPROPRIATE FIELDS IN SECTION D HAVE BEEN UPDATED. THE GRADE OF CAPSULAR CONTRACTURE WAS II. ADDITIONALLY, THE PATIENT REPORTS SYMPTOMS OF BREAST IMPLANT ILLNESS, INCLUDING PAIN, MAST CELL ACTIVATION SYNDROME AND SWOLLEN LYMPH NODES. H6 HEALTH EFFECT ¿ CLINICAL CODES HAVE BEEN UPDATED. FURTHERMORE, MENTOR LEARNED THAT THE PATIENT HAD A REVISION FOR RIGHT-SIDED CAPSULAR CONTRACTURE ON (B)(6) 2011, AND THAT THE DEVICE WAS EXPLANTED AND SUBSEQUENTLY REINTRODUCED AT THIS TIME. H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. 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. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE THAT THE DEVICES ARE NO LONGER AVAILABLE. HENCE, FIELD H6 FOR TYPE OF INVESTIGATION HAS BEEN UPDATED TO "DEVICE DISCARDED." THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. 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: CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, PAINFUL UNDERARM LYMPH NODES, AND HYPERSENSITIVITY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH UNKNOWN GEL IMPLANTS ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, PAINFUL UNDERARM LYMPH NODES, AND HYPERSENSITIVITY POSTOPERATIVELY. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995470 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5926848

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention