FLYTE HELMET 0408600000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-12 for FLYTE HELMET 0408600000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[30983098] It was reported that during testing conducted at the user facility the device was overheating. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[32603726] The device was tested and no failures were found. The device was scrapped.
Patient Sequence No: 1, Text Type: N, H10


[32603727] It was reported that during testing conducted at the user facility the device was overheating. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2015-04115
MDR Report Key5219804
Report SourceCOMPANY REPRESENTATIVE
Date Received2015-11-12
Date of Report2015-10-19
Date of Event2015-10-19
Date Mfgr Received2015-12-02
Device Manufacturer Date2015-06-24
Date Added to Maude2015-11-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLYTE HELMET
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2015-11-12
Returned To Mfg2015-10-20
Catalog Number0408600000
Device AvailabilityR
Device Age3 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-12

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