BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER

    MDR report key: 17259241 · Received July 5, 2023

    Report

    Report Number
    1645337-2023-07802
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    May 20, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    MRD
    PMA / PMN Number
    P030053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: PRE-IMPLANT RUPTURE. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 7, 2023, THE FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM: 1. UPDATED FROM LOT NUMBER 9884487 TO LOT NUMBER 9873576 UNDER FIELD D4; INFORMATION UNDER SECTION D HAS BEEN UPDATED ACCORDINGLY 3. PER THE LOT NUMBER UPDATED, PRODUCT EXPERIENCE CODE WAS AUTOMATICALLY REMOVED. 4. ADDED PRODUCT EXPERIENCE CODE: DEFLATION (PRE-IMPLANT) 5. REPORTABILITY DECISION HAS BEEN UPDATED FROM MALFUNCTION TO NOT REPORTABLE MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 375CC MENTOR MEMORYGEL BREAST IMPLANTS BEING USED FOR A BREAST AUGMENTATION PROCEDURE RUPTURED PRIOR TO IMPLANTATION, AND BUBBLE WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775335 MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS 3503754BC 9873576
    2053215 MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS 3503754BC 9873576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown