BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    MDR report key: 14492717 · Received May 24, 2022

    Report

    Report Number
    1645337-2022-06028
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317006558
    PMA / PMN Number
    K130813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: TISSUE EXPANDER DEFLATION. 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).

    Additional Manufacturer Narrative · 0

    ON 06-JUN-2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. IT WAS PREVIOUSLY REPORTED THAT THE DEVICE IS A CE MED HEIGHT TE 550CC TISSUE EXPANDER WITH CATALOG #3548224. NEW INFORMATION RECEIVED STATES THAT THE DEVICE IS A MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC DEVICE, CATALOG #3548214, LOT #9503008, UDI (B)(4), 510(K) #K130813. 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. 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: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 06-JUL-2022, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED DEFLATION IN THE TISSUE EXPANDER. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE TISSUE EXPANDER. LEAK TESTING WAS PERFORMED AND IT REVEALED A TEAR AT THE JUNCTURE OF THE SHELL AND ANTERIOR PATCH. A MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A CE MED HEIGHT TE 550CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755312 MENTOR CPX 4 BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 3548214 9503008 00081317006558

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention