BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 7866161 · Received September 11, 2018

    Report

    Report Number
    1645337-2018-05490
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    April 30, 2018
    Report Date
    August 27, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09/12/2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 165252 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/22/2018, 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. BROWN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.6 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. 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 BROWN MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE RECEIVED WAS SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE. CORRECTION: ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE RECORD REVIEW WAS IN PROCESS FOR THE LOT NUMBER OF AFFECTED PRODUCT, BUT THE LOT NUMBER WAS NOT INDICATED. THE ACTUAL LOT NUMBER IS 165252. THE CONCOMITANT PRODUCT IS MENTOR SALINE BREAST IMPLANT OF UNKNOWN TYPE LOT NUMBER 161885. (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: MENTOR GEL BREAST IMPLANT OF UNKNOWN TYPE, LOT NUMBER 161885. 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 GEL MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED RUPTURE ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 325CC ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706858 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 165252

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention