BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE MED HEIGHT TE 650CC

    MDR report key: 7507585 · Received May 11, 2018

    Report

    Report Number
    1645337-2018-02808
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 19, 2018
    Report Date
    April 23, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 7/12/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2018. EXPLANTATION DATE: (B)(6) 2018. PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION. THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL PROSTHESIS ON (B)(6) 2018. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/18/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 7/26/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN DEVICE: BRAND NAME: CE MED HEIGHT TE 650CC. PROCODE: LCJ. COMMON DEVICE NAME: EXPANDER, SKIN, INFLATABLE. CATALOG: 3548225. LOT: 7386868. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AT MENTOR WITH CLEAR FLUID. DURING INITIAL EVALUATION THE DEVICE APPEARED INTACT. LEAK TESTING OF THE DEVICE, IN ACCORDANCE WITH MENTOR PROCEDURES, REVEALED A RENT ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.1CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE OBSERVED. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 7386868 HAS BEEN REVIEWED ON 8/1/2018, AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. BECAUSE THE RISK OF DEVICE DEFLATION CANNOT BE ELIMINATED, MENTOR ADDRESSES THIS RISK IN THE PIDS BY STATING THAT THESE DEVICES SHOULD NOT BE CONSIDERED LIFETIME DEVICES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAST TISSUE EXPANDER IMPLANTED. DEFLATION OF THE BREAST TISSUE EXPANDER WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE BREAST TISSUE EXPANDER WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350310 CE MED HEIGHT TE 650CC EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 7386868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention