BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LX300, WOLF PORT 300W

    MDR report key: 2588409 · Received May 23, 2012

    Report

    Report Number
    1222895-2012-00014
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    March 20, 2012
    Report Date
    May 23, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE EVENT, ELECTRICAL SHOCK, OCCURRED DURING AN UNK SURGICAL PROCEDURE ON (B)(6) 2012. CUSTOMER REPORTS THE HEALTHCARE PROFESSIONAL WAS "PLUGGING IN THE SURGEONS HEADLIGHT. GOT AN ELECTRICAL SHOCK, IT SHORTED OUT WALL PANEL. HEALTHCARE PROFESSIONAL THEN GOT TINGLING IN RIGHT ARM AND TIGHTNESS IN THE CHEST", AND DID NOT LOSE CONSCIOUSNESS. SHE WAS SEEN IN THE EMERGENCY ROOM FOR CLINICAL ASSESSMENT AND CLEARED TO WORK THE NEXT DAY. TREATMENT, ROUTINE CLINICAL MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LX300, WOLF PORT 300W NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR