BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11348463 · Received February 19, 2021

    Report

    Report Number
    1645337-2021-01757
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    November 23, 2020
    Report Date
    February 2, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 17, 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS PER DEVICE RECEIVED, THE FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM: - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR SMOOTH ROUND MODERATE PROFILE" - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3501635" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "5584940" - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "(B)(4)" - FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P990075" 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 · 0

    ON (B)(6) 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 250CC BREAST IMPLANT HAS VALVE DELAMINATED, CAUSING LEAKAGE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 19, 2021, MENTOR BECAME AWARE THAT FIELD E4 (REPORTER ALSO SENT REPORT TO FDA?) WAS MISTAKENLY MARKED AS "UNK" IN THE INITIAL REPORT. IT HAS BEEN CORRECTLY UPDATED TO "NO" ON THIS FORM. 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: RIGHT DEFLATION. (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN SIZE UNKNOWN SALINE IMPLANT AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501635; SERIAL NUMBER (B)(4) ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246091 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5584940

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention