BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE PRO MODULE

    MDR report key: 6266090 · Received January 20, 2017

    Report

    Report Number
    2523190-2017-00005
    Event Type
    Injury
    Date Received
    January 20, 2017
    Report Date
    December 23, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FST
    PMA / PMN Number
    K071218
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 1/172017 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE NOT AVAILABLE, NOT INTEGRA PRODUCT.. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - ALTHOUGH THE HEADBAND WAS INTEGRA, THE HEADLIGHT THAT WAS ATTACHED TO THE HEADBAND WAS NOT AN INTEGRA HEADLIGHT. THE HEADLIGHT IS WHAT MELTED, NOT THE HEADBAND. THERE IS NO ISSUE WITH THE HEADBAND. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THERE IS NO ISSUE WITH THE HEADBAND.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS CONNECTION BETWEEN THE PREMIUM CABLE AND ULTRALIGHT PRO HEADLAMP MELTED AND BURNED SURGEON. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51572 ULTRALITE PRO MODULE N/A FST INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other