BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE MED HEIGHT TE

    MDR report key: 10833609 · Received November 12, 2020

    Report

    Report Number
    1645337-2020-14530
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    August 1, 2020
    Report Date
    October 23, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED ON 12/8/2020, THAT DEVICE AVAILABLE FOR EVALUATION?, IS DEVICE RETURNED TO MANUFACTURER?, DATE DEVICE RETURNED TO MANUFACTURER WAS ERRONEOUSLY OMITTED IN FOLLOW UP REPORT 1. SEE CORRECTED DATA SECTION H.11 FOR CORRECTIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) CORRECTIONS. D9. DEVICE AVAILABLE FOR EVALUATION? YES . D9. IS DEVICE RETURNED TO MANUFACTURER? CHECKED . D9. DATE DEVICE RETURNED TO MANUFACTURER. 11/19/2020.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2020. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A DEFLATION IN A TISSUE EXPANDER. DURING THE VISUAL EVALUATION OF THE DEVICE, NO APPARENT DAMAGE WAS OBSERVED. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR'S PROCEDURES, AND IT REVEALED A TEAR AT THE JUNCTION BETWEEN THE SHELL AND ANTERIOR PATCH. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020, PATIENT IDENTIFIER IS S.G. THE MENTOR FAILURE ANALYSIS LAB HAS 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. 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 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 (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 450CC CE MED HEIGHT TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. PATIENT¿S TISSUE EXPANDER DEFLATED DUE TO DETACHMENT OF THE BUFFER PLATE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295009 CE MED HEIGHT TE EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 7672052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention