FLYTE SURGICOOL HOOD, PEELAWAY 0408801500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-11 for FLYTE SURGICOOL HOOD, PEELAWAY 0408801500 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[85628970] It was reported that during a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product. The procedure was completed successfully without a clinically significant delay. There were no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


[115077653] Follow-up report submitted to document device evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[115077654] It was reported that during a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product. The procedure was completed successfully without a clinically significant delay. There were no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2017-01804
MDR Report Key6854781
Report SourceUSER FACILITY
Date Received2017-09-11
Date of Report2017-10-18
Date of Event2017-08-14
Date Mfgr Received2017-10-17
Device Manufacturer Date2017-10-17
Date Added to Maude2017-09-11
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 SURGICOOL HOOD, PEELAWAY
Generic NameHOOD, SURGICAL
Product CodeFXY
Date Received2017-09-11
Returned To Mfg2017-08-31
Catalog Number0408801500
Lot Number17030540
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2017-09-11

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