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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0408600000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device had no device problem found.  additional information: 1 device is labeled for single-use.1 device was not reprocessed and reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly overheated.1 event had patient involvement; no patient impact.
 
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Brand Name
FLYTE HELMET
Common Device Name
HELMET, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8816160
Report Number0001811755-2019-02383
Device Sequence Number16731476
Product Code FXZ
UDI-Device Identifier04546540591579
UDI-Public04546540591579
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number0408600000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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