BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE TALL HGT TE W/SUT TAB 350CC

    MDR report key: 21608732 · Received March 14, 2025

    Report

    Report Number
    1645337-2025-02760
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 7, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317009320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 17, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE CORRECT SUSPECT MEDICAL DEVICE WAS CE TALL HGT TE W/SUT TAB 350CC CATALOG: 3549322 LOT: 9791082. 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. ON MARCH 19, 2025, 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.

    Additional Manufacturer Narrative · 0

    ON MAY 18, 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. DURING THE VISUAL ANALYSIS OF THE RETURNED DEVICE, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT REVEALED A TEAR ON THE POSTERIOR VIEW, BETWEEN THE UNION OF THE BASE AND SHELL AT THE 1 O'CLOCK POSITION. NO OTHER LEAK SITES WERE FOUND DURING THE ANALYSIS. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AS PART OF THIS EVALUATION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A NOTIFICATION WAS SENT TO MENTOR'S MANUFACTURING TEAM FOR FURTHER INVESTIGATION. ACCORDING TO THE MANUFACTURING INVESTIGATION, POTENTIAL PROCESS FAILURES RESULTING IN A RUPTURE THAT MAY REPRESENT DEFLATION WERE ASSESSED REGARDING THE PRODUCT COMPLAINT. IN CONCLUSION, CONSIDERING THE PROCESS CONTROLS, THE EVALUATION PERFORMED, AND DATA RECORDS REVIEWED ON THE COMPLAINT DEVICE, THE DEFLATION REPORTED IN THIS PRODUCT COMPLAINT IS NOT ABLE TO BE CONFIRMED AS A MANUFACTURING-RELATED DEFECT. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: THE SILICONE SHELL OF THE TISSUE EXPANDER MAY EASILY BE CUT BY A SCALPEL OR RUPTURED BY EXCESSIVE STRESS, MANIPULATION WITH BLUNT INSTRUMENTS, OR PENETRATION BY A NEEDLE. SUBSEQUENT DEFLATION AND/OR RUPTURE COULD RESULT. ALL DEVICES SHOULD BE CAREFULLY INSPECTED FOR STRUCTURAL INTEGRITY PRIOR TO AND DURING IMPLANTATION. IN ADDITION, THE PATIENT SHOULD BE ADVISED THAT VIGOROUS BODY MOVEMENT (E.G., PHYSICAL EXERCISE) OR EXCESSIVE MANIPULATION OR TRAUMA IN THE EXPANDER REGION MAY CAUSE STRESS TO THE DEVICE AND RESULT IN SUBSEQUENT DEFLATION. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    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 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: DEFLATION. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A CE MED HGT TE W/SUT TABS 350CC. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228224 CE TALL HGT TE W/SUT TAB 350CC EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9791082 00081317009320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention