BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9005917 · Received September 12, 2019

    Report

    Report Number
    1645337-2019-18809
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000464
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 10/4/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE. DURING EVALUATION OF THE SAMPLE IT WAS OBSERVED TO BE INTACT. NO ANOMALIES WERE OBSERVED. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER ANY DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS, HOWEVER COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED BY QUALITY ASSURANCE TO DETERMINE IF FURTHER ACTION IS NECESSARY. 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 (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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE BAKER'S GRADE III. CONCOMITANT MEDICAL PRODUCTS: 300CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC LOT: 6936156 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 300CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE BAKER¿S GRADE III POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE BAKER¿S GRADE III WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 300CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC LOT:7701574 SN: (B)(4) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801485 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6944085 00081317000464

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention