BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE TRANSBLEPH 3.5MM BIOABSORBABLE IMPLANT

    MDR report key: 6297304 · Received January 31, 2017

    Report

    Report Number
    MW5067605
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 23, 2017
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOTINE TRANSBLEPH BROW LIFT IMPLANTS X 2 WERE IMPLANTED DURING A PROCEDURE IN (B)(6) 2016. THE PATIENT DEVELOPED BILATERAL INFLAMMATION AND ERYTHEMA. CT SCAN REVEALED ORBITAL SWELLING, POSSIBLE ABSCESS, AND A METALLIC FOREIGN BODY ABUTTING THE ANTERIOR LEFT SUPRAORBITAL BONE. THE INFLAMMATORY RESPONSE WAS NOTED GREATER ON THE LEFT SIDE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND BOTH IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73393 ENDOTINE TRANSBLEPH 3.5MM BIOABSORBABLE IMPLANT ENDOTINE HWC MICROAIRE SURGICAL INSTRUMENTS, LLC 259480
    73394 ENDOTINE TRANSBLEPH 3.5MM BIOABSORBABLE IMPLANT ENDOTINE HWC MICROAIRE SURGICAL INSTRUMENTS, LLC 259480

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention