BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7849223 · Received September 5, 2018

    Report

    Report Number
    1645337-2018-05407
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    July 30, 2018
    Report Date
    August 14, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001294
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2/28/2019, A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 5780060 WAS PERFORMED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. THE MRE VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IN ADDITION, NO OTHER RELATED COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT NUMBER. THE MANUFACTURING PROCESS (FROM SHELL FABRICATION TO SECONDARY PACKAGING) WAS REVIEWED FOR FOREIGN MATTER/ PARTICULATE CONTROL AT MENTOR IRVING'S CME (CONTROLLED MANUFACTURING ENVIRONMENT), WHICH INCLUDES SHELL FABRICATION, MAIN ASSEMBLY, PRIMARY PACKAGING AREAS, GAMMA STERILIZATION, AND SECONDARY PACKAGING AREAS. AT MULTIPLE POINTS DURING THE MANUFACTURING PROCESS, DEVICES WITHIN THE LOT ARE PROCESSED TO ENSURE ANY FOREIGN MATTER, PARTICULATES OR CONTAMINANTS ARE REMOVED. ADDITIONALLY, 100% OF DEVICES ARE VISUALLY INSPECTED FOR ANY DEFECTS, INCLUDING FOREIGN MATTER OR PARTICULATES. THESE DEVICES ARE SUBSEQUENTLY REJECTED WHEN IDENTIFIED. ALL MANUFACTURING AREAS WHERE THE SHELL OR DEVICE IS EXPOSED TO THE ENVIRONMENT ARE CONTROLLED MANUFACTURING ENVIRONMENTS (CME). GOWNING IS REQUIRED AND STRICTLY ENFORCED FOR ALL INDIVIDUALS ENTERING DESIGNATED CMES AT MENTOR, WHETHER THEY ARE MENTOR EMPLOYEES, VISITORS OR CONTRACTORS. THE CME GARMENTS CONSIST OF HAIR COVERINGS (BOUFFANT AND/OR HOOD), FROCK OR JUMPSUIT, AND SHOE OR BOOT COVERS. STERILIZATION RECORDS WERE ALSO REVIEWED FOR PRODUCT CODE 3501680, LOT# 5780060. ENVIRONMENTAL MONITORING FOR VIABLE AIRBORNE PARTICULATES AND SURFACE MICROBIALS IS ROUTINELY PERFORMED IN EACH CONTROLLED MANUFACTURING ENVIRONMENT. REVIEW OF THE ENVIRONMENTAL MONITORING DATA FOR VIABLE AIRBORNE PARTICULATES AND SURFACE MICROBIALS DURING THE MANUFACTURING OF PRODUCT CODE 3501680, LOT# 5780060 IDENTIFIED ACCEPTABLE RESULTS, ALLOWING FOR RELEASE OF THE LOT. NON-VIABLE PARTICULATES ARE MEASURED ON A QUARTERLY BASIS. REVIEW OF THE NON-VIABLE PARTICULATES DATA FOR PERIODS BEFORE AND AFTER THE MANUFACTURE OF PRODUCT CODE 3501680, LOT# 5780060 WERE REVIEWED, AND NO EXCURSIONS WERE IDENTIFIED. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. INFECTION, MANIFESTED BY SWELLING, TENDERNESS, PAIN AND FEVER, MAY APPEAR IN THE IMMEDIATE POSTOPERATIVE PERIOD OR AT ANY TIME AFTER INSERTION OF THE IMPLANT. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY. THE APPLICATION FAILURE MODES AND EFFECTS ANALYSIS WAS REVIEWED FOR THE DEFECT IN QUESTION (FOREIGN MATTER/MOLD) AND THE HAZARD RISK WAS DETERMINED TO BE AS LOW AS POSSIBLE, WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION WILL BE COMPLETED. 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 8/20/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 475CC SALINE PROSTHESIS. THE PATIENT WOKE UP AND NOTICED DEFLATION ON THE RIGHT BREAST PROSTHESIS POST PROCEDURE. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018. THE PATIENT REPORTED THAT THERE WAS MOLD IN THE DEVICE¿S VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688374 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5780060 00081317001294

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention