BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9092677 · Received September 19, 2019

    Report

    Report Number
    1645337-2019-19746
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS, CATALOG #3501655, LOT #162337, UDI # (B)(4), PMA #P990075. - MENTOR ATTEMPTED TO PERFORM A MANUFACTURING RECORD EVALUATION (MRE) ON THE REPORTED LOT NUMBER 162337, BUT MENTOR COULD NOT CONFIRM THIS LOT NUMBER. MULTIPLE ATTEMPTS WERE MADE TO GET CLARIFICATION ABOUT THE LOT NUMBER. HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AND THE MRE COULD NOT BE PERFORMED. IF CLARIFICATION IS RECEIVED IN THE FUTURE, THE MRE WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. - THE CONCOMITANT PRODUCT IS A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS, CATALOG #3501655, LOT #162337. - THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/24/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: IT WAS INITIALLY REPORTED THAT THE IMPLANTATION DATE IS (B)(6) 1997. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 1999. THE PATIENT HAD BOTH OF HER BREAST PROSTHESES REMOVED AND THEY WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT 295CC GEL BREAST PROSTHESES. ON 10/29/2019, 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEFLATION ON THE IMPLANT. DURING VISUAL EVALUATION OF THE SAMPLE IT WAS NOTICED A CREASE IN THE POSTERIOR VIEW. WITHIN THE CREASE, A TEAR A WAS NOTED, MEASURING APPROXIMATELY 0.1 CM. IN ADDITION, A TEAR B WAS LOCATED AT THE SAME ASPECT OF THE TEAR A, MEASURING APPROXIMATELY 7.0 CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RUPTURE B REVEALED PARALLEL STRIATIONS. NO OTHER ANOMALIES WERE OBSERVED. THE STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. AS STATED IN THE PRODUCT INSERT DATA SHEET, DO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES AS THIS CAN RESULT IN RUPTURE. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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 REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879936 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 162337

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R