BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 7874592 · Received September 13, 2018

    Report

    Report Number
    1645337-2018-05565
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 16, 2018
    Report Date
    August 28, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09/20/18, IT WAS REPORTED TO MENTOR THAT THE PATIENT HAD FULLY RECOVERED AND IMPROVED AFTER THE SURGERY. THE DEFLATION WAS NOTICED BY THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED. RIGHT SIDE HAD CALCIFICATION OF CAPSULE FOUND DURING SURGERY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 1 CM AND A CREASE ON THE ANTERIOR ASPECT. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PRODUCT EVALUATION TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE DISCOVERED. THE LOT NUMBER WASN'T VISIBLE DUE THE PATCH WAS FOUND COVER UP WITH DRY SALINE SOLUTION. 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 OR THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON THE DEVICE. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR BREAST IMPLANTS OF UNKNOWN TYPE AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC, CATALOG NUMBER: 3502325, SERIAL NUMBER: (B)(4), LOT NUMBER: 7338948 ON THE LEFT BREAST IMPLANT AND WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC, CATALOG NUMBER: 3502325, SERIAL NUMBER: (B)(4), LOT NUMBER: 6895886 ON THE RIGHT BREAST IMPLANT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715408 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR