BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND SPECTRUM

    MDR report key: 7520880 · Received May 16, 2018

    Report

    Report Number
    1645337-2018-02976
    Event Type
    Injury
    Date Received
    May 16, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002116
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/15/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE WAS RECEIVED WITHOUT FLUID. BROWN MATERIAL WAS OBSERVED WITHIN DEVICE. DEVICE APPEARS WITH SHELL WEAR ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE OBSERVED. A ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. CORRECTIVE ACTION: BECAUSE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BLIND DEVICE RECEIVED IN PRODUCT EVALUATION LAB WITH NO COMPLAINT INFORMATION ATTACHED AND COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. DEVICE APPEARS WITH SHELL WEAR ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE OBSERVED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 06/22/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED ON (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 05/22/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 5862833 HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: SALINE MENTOR SILTEX ROUND SPECTRUM 425CC BREAST IMPLANT , LOT NUMBER 5862833. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, SALINE MENTOR SILTEX ROUND SPECTRUM 425CC BREAST IMPLANTS WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICES COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362183 MENTOR SILTEX ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5862833 00081317002116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention