BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FLYTE BATTERY POWERED LIGHTED HELMET

    MDR report key: 11728534 · Received April 26, 2021

    Report

    Report Number
    3015967359-2021-00547
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 29, 2021
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    FXZ
    UDI-DI
    04546540591609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE: 2 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 2 DEVICES WERE RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. 2 DEVICES WERE NOT LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622047 FLYTE BATTERY POWERED LIGHTED HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 0408645000 04546540591609

    Patients

    Seq Age Sex Outcome Treatment
    1