BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PROFILE MODERATE GEL - LUMERA

    MDR report key: 9279093 · Received November 5, 2019

    Report

    Report Number
    1645337-2019-23077
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE SUSPECTED MEDICAL DEVICE. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. ON (B)(6) 2020, IT WAS FOUND THAT THE EXPIRATION DATE, 4-NOV-2009, WAS MISTAKENLY ENTERED IN D.7. EXPLANTATION DATE FIELD ON THE PREVIOUS REPORT. D.4. EXPIRATION DATE HAS BEEN UPDATED WITH THE EXPIRATION DATE, 4-NOV-2009, AND D.7. EXPLANTATION DATE HAS BEEN UPDATED AS (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    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. 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT-SIDED RUPTURE. CONCOMITANT PRODUCTS: 220CC CONTOUR PROFILE MODERATE GEL ¿ LUMERA, ( CATALOG #: 3241107; SERIAL #: (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 ENROLLED IN A CLINICAL STUDY AND UNDERWENT A REVISION BREAST AUGMENTATION WITH A 220CC CONTOUR PROFILE MODERATE GEL - LUMERA EXPERIENCED POSTOPERATIVE RIGHT-SIDED RUPTURE. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED IMPLANTS ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073101 CONTOUR PROFILE MODERATE GEL - LUMERA PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5562363

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention