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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, XL, PULLOVER; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, XL, PULLOVER; GOWN, SURGICAL Back to Search Results
Catalog Number 0408731000
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2019
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility, the device was found to be ripped.There was no medical intervention and no adverse consequences with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
FLYTE SURGICOOL TOGA, XL, PULLOVER
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10098369
MDR Text Key193087212
Report Number0001811755-2020-01337
Device Sequence Number1
Product Code FYA
UDI-Device Identifier37613327117074
UDI-Public37613327117074
Combination Product (y/n)N
Reporter Country CodeJP
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 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408731000
Device Lot Number19030528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Date Manufacturer Received05/25/2020
Was Device Evaluated by Manufacturer? Yes
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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