BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 11302201 · Received February 9, 2021

    Report

    Report Number
    1645337-2021-01279
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    December 5, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001683
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT¿S SYMPTOMS. INITIALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT-SIDED IMPAIRED HEALING. HOWEVER, ADDITIONAL INFORMATION REVEALED THAT THE PATIENT EXPERIENCED RIGHT-SIDED DEVICE EXTRUSION. H6 HEALTH EFFECT - CLINICAL CODE : POCKET EROSION (E200601). UPDATED REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEVICE EXTRUSION. 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: IMPAIRED HEALING MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 500CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESES AND EXPERIENCED LEFT-SIDED DEFLATION AND RIGHT-SIDED IMPAIRED HEALING POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO 500CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESES (CATALOG#: 3503500 , LEFT SERIAL #: (B)(4), RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021. AFTER THE REVISION SURGERY, THE PATIENT¿S SYMPTOMS WERE IMPROVED. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195952 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3503500 9495760 00081317001683

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention