BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNONWN SALINE BREAST PROSTHESIS

    MDR report key: 15442149 · Received September 16, 2022

    Report

    Report Number
    1645337-2022-10770
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    January 1, 2015
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: WOUND INFECTION, IMPAIRED HEALING, CAPSULAR CONTRACTURE, BREAST PAIN, ANISOMASTIA, PATIENT DISSATISFACTION WITH PROCEDURE OUTCOME, EARLY ONSET SEROMA, HYPERTROPHIC SCAR, NEOPLASM MALIGNANT, IMPLANT SITE HEMATOMA, ANAPLASTIC LARGE-CELL LYMPHOMA, SOFT TISSUE INJURY, GENERALIZED ILLNESS, DEFLATION, AND DEVICE MIGRATION. (B)(4). MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    GIVEN THE MODALITY OF THE COMPLAINT RECEIPT WITH THE INITIAL REPORT OF BIA- ALCL WITH NO PATHOLOGY/CYTOLOGY REPORT PROVIDED, FOLLOW-UP IS NOT POSSIBLE. PER THE INFORMATION PROVIDED, IT¿S UNKNOWN IF THE PATIENTS IMPACTED HAD ANY HISTORY OF PREVIOUS BREAST IMPLANTS; THE PREVIOUS IMPLANT HISTORY IS UNKNOWN. BASED ON THE REPORT SOURCE (I.E., DRRA), THESE CASES ARE NOT AND CANNOT BE PATHOLOGICALLY OR CYTOLOGICALLY CONFIRMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SALINE IMPLANTS. THE REPORT SHOWED ISSUES IDENTIFIED DURING BREAST IMPLANT REVISION PROCEDURES FOR RECONSTRUCTIVE AND AESTHETIC PERMANENT IMPLANTS (2020). MULTIPLE ISSUES WERE REGISTERED PER REVISION, EITHER AS THE REASON FOR REVISION OR FOUND INCIDENTALLY DURING THE REVISION PROCEDURE. ADVERSE EVENT(S) REPORTED FOR MENTOR SALINE BREAST IMPLANTS USED DURING BREAST IMPLANT REVISION PROCEDURES FOR RECONSTRUCTIVE AND AESTHETIC PERMANENT IMPLANTS IN 2020. QTY 83: DEEP WOUND INFECTION, QTY 54: SKIN NECROSIS OR DEHISCENCE, QTY 156: CAPSULAR CONTRACTURE, QTY 113: BREAST PAIN, QTY 88: ASYMMETRY, QTY 229: DISSATISFIED WITH VOLUME, QTY 37: SEROMA, QTY 21: SKIN SCARRING, QTY 19: NOT STATED, QTY 15: BREAST CANCER, QTY 14: FLAP PROBLEM, QTY 11: HEMATOMA, QTY 55: DEFLATION, QTY 65: SUSPICION OF BREAST IMPLANT-ASSOCIATED ILLNESS, QTY 10: BIA-ALCL (SUSPICION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467593 UNKNONWN SALINE BREAST PROSTHESIS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L