BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHATTANOOGA

    MDR report key: 5529887 · Received March 28, 2016

    Report

    Report Number
    2020737-2016-00003
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    March 18, 2016
    Report Date
    September 28, 2016
    Manufacturer
    LPG SYSTEMS
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "DURING TREATMENT PATIENT'S 4TH DIGIT ON THEIR LEFT HAND WAS ENTRAPPED BETWEEN THE JOINT OF THE OPTIFLEX K1 EXTENSION ARM. THE MACHINE STOPPED BUT DID NOT RELEASE THE PATIENT'S FINGER. THE STAFF HAD TO USE TOOLS TO MANUALLY RELEASE THE PATIENT'S FINGER. WARRANTY. INJURIES SUSTAINED: REDNESS, SWELLING, BRUISING". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186146 CHATTANOOGA OPTIFLEX ®K1 BXB LPG SYSTEMS 2026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other