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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, XL, ZIPPER; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, XL, ZIPPER; GOWN, SURGICAL Back to Search Results
Catalog Number 0408831000
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
Discarded at account.
 
Event Description
It was reported that during a surgical procedure at the user facility, the surgeon's toga had bleed through on his chest-area to the scrubs.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
 
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Brand Name
FLYTE SURGICOOL TOGA, XL, ZIPPER
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7046111
MDR Text Key92986331
Report Number0001811755-2017-02364
Device Sequence Number1
Product Code FYA
UDI-Device Identifier7613327117127
UDI-Public(01)7613327117127
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408831000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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