BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7515552 · Received May 15, 2018

    Report

    Report Number
    1645337-2018-02918
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001812
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR ON 6/7/2018, THE DEVICE RECEIVED WITHOUT FLUID. EXAMINATION OF THE DEVICE REVEALED A RENT MEASURING 0.5 CM NEAR TO AN AREA OF SILTEX CRACKING ON THE ANTERIOR ASPECT. PARALLEL LINES OF SHELL WEAR WERE OBSERVED ON BOTH ASPECTS. NO OTHER ANOMALIES WERE OBSERVED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE: PRODUCT EVALUATION CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. A POSSIBLE CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. A COMPLAINT OF CAPSULAR CONTRACTURE IN THE BREAST WAS REPORTED, WITH THE INFORMATION PROVIDED, PRODUCT EVALUATION CONCLUDED THE REPORTED COMPLAINT OF CAPSULAR CONTRACTURE IN THE PATIENT WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE AND DEFLATION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THESE DEVICES AND ARE REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 217452 REVIEWED 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/16/2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. ON 5/31/2018, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT BREAST. IN ADDITION, ON 6/1/2018, MENTOR BECAME AWARE THAT THE GRADE FOR THE CAPSULAR CONTRACTURE WAS I-II. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: LOT #190143. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESIS. LEFT BREAST PROSTHESIS DEFLATION WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356947 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 217452 00081317001812

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention