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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAY; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAY; GOWN, SURGICAL Back to Search Results
Catalog Number 0408841100
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2016
Event Type  malfunction  
Event Description
The customer reported that the seam in the sleeve of the toga tore open during a procedure at the user facility.The procedure was completed successfully with no delay, no adverse consequences, and no medical intervention.
 
Event Description
The customer reported that the seam in the sleeve of the toga tore open during a procedure at the user facility.The procedure was completed successfully with no delay, no adverse consequences, and no medical intervention.
 
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Brand Name
FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAY
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 Key6190832
MDR Text Key62911081
Report Number0001811755-2016-02878
Device Sequence Number1
Product Code FYA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/28/2018
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 Number0408841100
Device Lot Number16091481
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2016
Initial Date FDA Received12/20/2016
Supplement Dates Manufacturer Received03/28/2018
Supplement Dates FDA Received03/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2016
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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