BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9273890 · Received November 4, 2019

    Report

    Report Number
    1645337-2019-21238
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    March 1, 2015
    Report Date
    April 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003809
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION #E2007003. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT A PATIENT FELT HER LEFT BREAST APPEARS SMALL AND IS PUCKERING UP SINCE TIME AGO. ALSO REPORTED THAT SHE IS EXPERIENCING A BURNING SENSATION. DURING EXAMINATION OF THE SAMPLE, A CREASE WAS OBSERVED. NO ADDITIONAL ANOMALIES WERE DISCOVERED. BASED ON THE FACTS OF THE CASE, IS UNRELATED TO THE BREAST IMPLANT AND RELATED TO THE PATIENT CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5921193, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT DUE TO EXTERNAL CAUSE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT THE PATIENT EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PAIN, WRINKLING, PARESTHESIA. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED BREAST PAIN, WRINKLING, AND PARESTHESIA. THE PATIENT REPORTED THAT HER LEFT BREAST APPEARS SMALL AND IS PUCKERING UP, AND THAT SHE IS ALSO EXPERIENCING A BURNING SENSATION. THE PATIENT SAW HER PHYSICIAN AND HAD AN ULTRASOUND PERFORMED; THE ULTRASOUND INDICATED POSSIBLE LEFT IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH ALLERGAN DEVICE ON (B)(6) 2019. UPON REMOVAL, IT WAS OBSERVED THAT THE EXPLANTED DEVICE DID NOT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068988 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5921193 00081317003809

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention