BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9632603 · Received January 27, 2020

    Report

    Report Number
    1645337-2020-01278
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    December 25, 2019
    Report Date
    January 6, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EXPLANTATION DATE WAS RESCHEDULED TO (B)(6) 2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. DEVICE EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE DEVICE NO APPARENT DAMAGE COULD BE OBSERVED. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. THE ANALYSIS WAS¿UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT MEDICAL PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 300CC, CATALOG NUMBER 3501645, LOT NUMBER 193386. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 300CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94600 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 193386

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention