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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 11/28/2016
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.
 
Manufacturer Narrative
Additional information: product was lost.No device evaluation.
 
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 Key6199697
MDR Text Key63133210
Report Number0001811755-2016-02892
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 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408841100
Device Lot Number16091565
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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