BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 10236691 · Received July 6, 2020

    Report

    Report Number
    1645337-2020-08191
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    March 3, 2020
    Report Date
    June 15, 2020
    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 JULY 17, 2020, MENTOR BECAME AWARE OF THE FOLLOWING, AND CORRESPONDING FIELDS HAVE BEEN UPDATED ON THIS FORM: - PATIENT IDENTIFIER POPULATED AS (B)(6) UNDER FIELD A1. - PATIENT AGE POPULATED AS 27 UNDER FIELD A2. - IMPACTED PRODUCT WAS 250CC MENTOR SMOOTH ROUND MODERATE PROFILE; FIELD D1 UPDATED. - CATALOG NUMBER POPULATED AS 3501635 UNDER FIELD D4. - LOT AND SERIAL NUMBERS POPULATED AS 6891809, AND (B)(6) RESPECTIVELY UNDER FIELD D4. - UNIQUE IDENTIFIER( UDI) POPULATED AS (B)(4) UNDER FIELD D4. - PMA/ 510(K) NUMBER UNDER FIELD G5 HAS BEEN UPDATED TO P990075. - THE REPLACEMENT DEVICE USED WAS CATALOG NUMBER 3501635; LOT NUMBER 9359120, AND SERIAL NUMBER (B)(6). A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION OF THE DEVICE NO APPARENT DAMAGE WAS OBSERVED. LEAK TESTING WAS PERFORMED, ACCORDING WITH MENTOR PROCEDURE, AND AN ANOMALY WAS OBSERVED ON THE POSTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR WAS ALSO OBSERVED WITHIN THE CREASE/FOLD MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD DEFLATION OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A DEFLATION IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 21, 2020, 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. ALSO, ON SEPTEMBER 21, 2020, MENTOR BECAME AWARE THAT DATE OF IMPLANTATION WAS (B)(6) 2015, WHICH WAS INADVERTENTLY MISSED UNDER PREVIOUS SUBMISSION MADE ON JULY 29, 2020. IT WAS REPORTED AS (B)(6) 2015 IN THE INITIAL REPORT. IT HAS BEEN CORRECTLY UPDATED UNDER FIELD D6 TO (B)(6) 2015 ON THIS FORM. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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

    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: LEFT DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN SIZE UNKNOWN SALINE IMPLANT AND WAS PRESENTED WITH BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697561 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6891809

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention