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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 Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Event Description
The customer reported that white dust particles came off of the device during the procedure.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences.
 
Event Description
The customer reported that white dust particles came off of the device during the procedure.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences.
 
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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
MDR Report Key7370200
MDR Text Key103524680
Report Number0001811755-2018-00539
Device Sequence Number1
Product Code FYA
Combination Product (y/n)N
PMA/PMN Number
K060076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/27/2018
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
Device Operator Health Professional
Device Catalogue Number0408800000
Device Lot Number17082292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received03/26/2018
Supplement Dates Manufacturer Received08/27/2018
Supplement Dates FDA Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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