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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HOOD; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE HOOD; GOWN, SURGICAL Back to Search Results
Catalog Number 0408800000
Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2015
Event Type  malfunction  
Event Description
It was report that at the user facility, there was a foreign substance present inside the sterile packaging of the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was not returned for evaluation.
 
Event Description
It was report that at the user facility, there was a foreign substance present inside the sterile packaging of the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
FLYTE HOOD
Type of Device
GOWN, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5232396
MDR Text Key31736870
Report Number0001811755-2015-04172
Device Sequence Number1
Product Code FYA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408800000
Device Lot Number15081385
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age8 MO
Date Manufacturer Received02/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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