BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8899627 · Received August 15, 2019

    Report

    Report Number
    1645337-2019-17281
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/30/2019, IT WAS NOTICED THAT THE DEVICE INFORMATION WAS ERRONEOUSLY ENTERED INCORRECTLY IN THE INITIAL REPORT SUBMITTED ON 8/15/2019. THE COMPLAINT DEVICE AND CONTRALATERAL DEVICE ARE BOTH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 275CC BREAST IMPLANTS, CATALOG NUMBER 3501640, LOT NUMBER 241880. 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

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. 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 SALINE BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING NUMBNESS IN BOTH ARMS AND HANDS, TREMBLING IN RIGHT ARM AND HAND, CHRONIC BOWEL PROBLEMS, DIGESTIVE ISSUES, THICKENING OF SIGMOID, COLD HANDS, COLD FEET, HEART PALPITATION, MUSCLE FATIGUE, JOINT PAIN, LUMBAR PAIN, DEGENERATIVE DISC DISEASE, LUMBAR PAINS, BUMPS IN BOTH BREASTS WITH EPISODE OF GANGLION UNDER RIGHT ARMPIT AND UNDER MY RIGHT SIDE BREAST, ACUTE PROBLEMS WITH SIGMOIDAL PAIN AND THICKENING, SHORTNESS OF BREATH, LOSS OF CONCENTRATION, MEMORY LOSS, LOSS OF LIBIDO, WATER RETENTION, EYES RED AND DRY, AND HAIR LOSS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693042 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 241880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other