BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 10681398 · Received October 14, 2020

    Report

    Report Number
    1645337-2020-13079
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001294
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED ADDITIONAL EVENT INFORMATION THAT THE PATIENT UNDERWENT REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT, 400CC ON THE LEFT (CATALOG # 3504001BC,LOT-SERIAL # (B)(6)) AND 425CC ON THE RIGHT (CATALOG # 3504251BC, LOT-SERIAL #(B)(6)) ON (B)(6)2020. THE MENTOR FAILURE ANALYSIS LAB HAS 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: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS COMPLETED THE EVALUATION OF THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR VIEW OF THE DEVICE EXTENDING TO THE POSTERIOR VIEW CONSISTENT WITH A CREASE/FOLD. A TEAR WAS ALSO FOUND WITHIN THE CREASE/FOLD ON THE POSTERIOR ASPECT MEASURING APPROXIMATELY 0.3 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 DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. A SECOND PRODUCT WAS RECEIVED 5990434 LOT NUMBER. NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED ADDITIONAL EVENT INFORMATION THAT THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6)2020. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. H6 PATIENT CODE 3191: MEDICAL DEVICE REMOVAL. 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. 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: N/A - THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 475CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION POST-OPERATIVELY. THE PATIENT STATED THAT SHE WAS HOLDING AN OBJECT ABOVE HER HEAD AND FELT AS IF SHE HAD PULLED A MUSCLE. TWO DAYS AFTER THE INCIDENT, THE PATIENT NOTICED THAT HER RIGHT-SIDED IMPLANT WAS FLAT, AND DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAM. 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
    1146121 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501680 5990434 00081317001294

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R