BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS SMOOTH

    MDR report key: 10939176 · Received December 3, 2020

    Report

    Report Number
    1645337-2020-15390
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    January 1, 2003
    Report Date
    November 19, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, MENTOR BECAME AWARE THAT PMA CODE WAS REPORTED INCORRECTLY AS : 4. PMA/ 510(K) P990075. THE ACTUAL CODE IS UNK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) PMA CODE IS UNK

    Additional Manufacturer Narrative · 0

    ON 1/12/2021, DURING VISUAL EVALUATION OF THE PICTURE THAT WAS RECEIVED ON 12/2/2020 NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED IN THE PRODUCT. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. GENERALIZED ILLNESS COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. NOTE: ON 12/2/2020, A PHOTO OF THE DEVICES WAS RECEIVED BY MENTOR. 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 PRIMARY WITH A MENTOR UNSPECIFIED SALINE IMPLANTS SMOOTH AND SUFFERED FROM THE FOLLOWING GENERALIZED ILLNESS SYMPTOMS: MEMORY AND NEUROLOGICAL ISSUES, SICKNESS, INFLAMMATION IN THE CHEST, A LOT OF PAIN, CHRONIC PAIN, CHRONIC FATIGUE, THE BODY JUST GAVE OUT, INFLAMMATORY MARKERS BEGAN TO SHOW UP. THE PATIENT FELT NAUSEA. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404743 UNKNOWN SALINE IMPLANTS SMOOTH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention