BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX ROUND MODERATE PROFILE

    MDR report key: 8537205 · Received April 22, 2019

    Report

    Report Number
    1645337-2019-10434
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    January 1, 2008
    Report Date
    March 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR BECAME AWARE THAT THE PATIENT HAD TWO SEPARATE ADVERSE EVENTS AND THAT THE FIRST EVENT REGARDING THE SUSPECT MEDICAL DEVICE REPORTED IN THE INITIAL REPORT SENT ON (B)(6) 2019, WAS INVOLVED ONLY IN MEDICAL DEVICE REMOVAL, PER AN INITIAL DETERMINATION OF RUPTURE VIA MRI. THE IMPLANT, ACCORDING TO THE PATIENT, TURNED OUT TO BE INTACT WHEN REMOVED. THE PATIENT STATED THAT THEY HAD UNDERGONE A PROCEDURE THAT WAS UNNECESSARY. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2008: (RIGHT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503501BC LOT: 5771597 SN: (B)(4) AND (LEFT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503501BC LOT: 5771597 SN: (B)(4). THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE SECOND ADVERSE EVENT CONCERNING ITCHING AT TIMES, PRESSURE, SWELLING AND HARDNESS AT THE TOP OF THE RIGHT SIDE REPLACEMENT DEVICE WAS REPORTED UNDER: 1645337-2019-13429 ON (B)(6) 2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. FOR "PRODUCT PROBLEM" WAS ERRONEOUSLY CHECK IN THE INITIAL REPORT SENT ON (B)(6) 2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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: N/A CONCOMITANT MEDICAL PRODUCTS: MENTOR SILTEX ROUND MOD. PROFILE GEL CATALOG: 3241257 LOT: 5668388 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR SILTEX ROUND MODERATE PROFILE GEL IMPLANTS, EXPERIENCED ITCHING AT TIMES, PRESSURE, SWELLING AND HARDNESS AT THE TOP OF THE RIGHT BREAST POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330378 SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5668388

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R