BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9139883 · Received October 1, 2019

    Report

    Report Number
    1645337-2019-20508
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000495
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 1932 WAS ERRONEOUSLY OMITTED IN INITIAL REPORT SUBMITTED ON 10/1/2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE PICTURE PROVIDED BY PATIENT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2019. DEVICE EVALUATION SUMMARY: ACCORDING WITH THE INFORMATION REPORTED SHE WAS SITTING UPSIDE WATCHING TV AND SHE FELT HEAT IN HER RIGHT BREAST, SHE EXPERIENCED BREAST PAIN, PARAESTHESIA AND A RUPTURE IN THE BREAST IMPLANT. UPON VISUAL INSPECTION OF THE PICTURE, IT WAS OBSERVED THAT THE IMPLANT WAS RUPTURE. NO OTHER ANOMALIES WERE OBSERVED. THE PHOTO DOES NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. MOST WOMEN UNDERGOING AUGMENTATION OR RECONSTRUCTION WITH A MAMMARY PROSTHESIS WILL EXPERIENCE SOME PAIN POSTOPERATIVELY. WHILE PAIN NORMALLY SUBSIDES IN MOST WOMEN AS THEY HEAL FROM SURGERY, IT CAN BECOME A CHRONIC PROBLEM IN OTHER WOMEN. CHRONIC PAIN CAN BE ASSOCIATED WITH A VARIETY OF FACTORS. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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: SYMPTOMATIC RUPTURE AND PAIN. CONCOMITANT MEDICAL PRODUCTS: 375CC SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT CATALOG: 3503754B LOT:5790151 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 375CC SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED SYMPTOMATIC RUPTURE AND PAIN POST PROCEDURE. A MAGNETIC RESONANCE IMAGERY WAS PERFORMED ON (B)(6) 2019 AND A CT SCAN ON (B)(6) 2019 WHICH CONFIRMED RIGHT SIDED RUPTURE. PATIENT ALSO MENTIONED THAT SHE WAS SITTING UPSIDE WATCHING TV AND SHE FELT HEAT IN HER RIGHT BREAST. MOREOVER, THE RIGHT SIDED SYMPTOMATIC RUPTURE WAS ALSO CONFIRMED BY A PHYSICIAN. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932243 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5790151 00081317000495

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention