BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FLYTE HOOD

    MDR report key: 16807668 · Received April 25, 2023

    Report

    Report Number
    3015967359-2023-00932
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 31, 2023
    Report Date
    July 27, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    FYA
    UDI-DI
    34546540591716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: 1 EVENT WAS PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER, 1 EVENT WAS REPORTED IN ERROR. 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. H3 OTHER TEXT : THERE ARE NO EVENTS TO REPORT FOR THIS CATALOG#/FAILURE.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE WAS RECEIVED. ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS CONTAMINATED WITH A CHEMICAL OR OTHER MATERIAL.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS CONTAMINATED WITH A CHEMICAL OR OTHER MATERIAL. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188028 FLYTE HOOD GOWN, SURGICAL FYA STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VMSR 34546540591716

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown