BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 12414111 · Received September 2, 2021

    Report

    Report Number
    1645337-2021-09808
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 13, 2021
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE OF THE IMPACTED DEVICE INFORMATION. HENCE, FOLLOWING FIELDS HAVE 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 "3501650" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "6881083" - 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 20, 2021, MENTOR BECAME AWARE WITH PAPERWORK RECEIVED WITH THE DEVICE THAT THE PATIENT ALSO EXPERIENCED RIGHT SIDE WOUND INFECTION AS PER THE INFORMATION, RIGHT SIDE IMPLANT WAS DAMAGED AND INFECTED. CLINICAL CODE WOUND INFECTION HAS BEEN ADDED TO FIELD H6 ON THIS FORM. HENCE, DEVICE WAS RE-EVALUATED ON OCTOBER 6, 2021, AND DEVICE EVALUATION SUMMARY WAS UPDATED WITH VERBIAGE REGARDING INFECTION AS STATED BELOW: MENTOR CONDUCTED VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT HAD A CREASE/FOLD ON THE ANTERIOR VIEW. ADDITIONALLY, WITHIN THE CREASE A TEAR MEASURING APPROXIMATELY 0.3 CM IN LENGTH WAS IDENTIFIED. LEAK TESTING WAS PERFORMED ACCORDING TO MENTOR PROCEDURE AND A SECOND TEAR WAS IDENTIFIED IN THE POSTERIOR VIEW MEASURING APPROXIMATELY 0.4 CM. THE EVALUATION DETERMINED THAT THE CAUSE OF THE DEFLATION WAS THE TRAUMA EXPERIENCED. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. TRAUMA IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. INFECTION, MANIFESTED BY SWELLING, TENDERNESS, PAIN AND FEVER, MAY APPEAR IN THE IMMEDIATE POSTOPERATIVE PERIOD OR AT ANY TIME AFTER INSERTION OF THE IMPLANT. IN THE ABSENCE OF CLASSIC SYMPTOMS, SUBACUTE OR CHRONIC INFECTIONS MAY BE DIFFICULT TO DIAGNOSE. IF INFECTION DOES NOT SUBSIDE PROMPTLY WITH THE APPROPRIATE TREATMENT, REMOVAL OF THE IMPLANT IS INDICATED. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY. PER THE DATABASE QUERY, THIS IS THE ONLY REPORTED COMPLAINT OF INFECTION AGAINST THIS LOT NUMBER. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE INDICATING THAT IT MEETS ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE A 10E-6 STERILITY ASSURANCE LEVEL PRIOR TO RELEASE FOR DISTRIBUTION. PRODUCT EVALUATION CONCLUDED THAT THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 20, 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON SEPTEMBER 23, 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT HAD A CREASE/FOLD ON THE ANTERIOR VIEW MEASURING APPROXIMATELY 0.3 CM IN LENGTH. LEAK TESTING WAS PERFORMED, ACCORDING TO MENTOR PROCEDURE, AND IT WAS IDENTIFIED A SECOND TEAR IN POSTERIOR VIEW MEASURING APPROXIMATELY 0.4 CM. MICROSCOPIC EXAMINATION WAS PERFORMED OVER THE RENT IN POSTERIOR VIEW, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. SINCE THE AUTHORIZATION FORM FOR THE EXAMINATION WAS NOT RECEIVED, THE PRODUCT EVALUATION LAB COULD NOT IDENTIFY A CONCLUSION DUE TO THE SPECIFIC NATURE OF THIS RUPTURE. THE EVALUATION WAS LIMITED TO NON-DESTRUCTIVE TESTING SO NO SHELL THICKNESS MEASUREMENT WAS CARRIED OUT. THE EVALUATION DETERMINED THAT THE CAUSE OF THE DEFLATION WAS THE TRAUMA EXPERIENCED. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. TRAUMA IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. 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. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. 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, AND CHEST INJURY (B)(4). 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 REVISION BREAST AUGMENTATION WITH A 325CC UNKNOWN SALINE IMPLANTS ON BOTH SIDES AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND RIGHT SIDE DEFLATION POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED VIA CT SCAN. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310237 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 6881083

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention