Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER; GOWN, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER; GOWN, SURGICAL Back to Search Results
Catalog Number 0408841000
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2020
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, the gown split at the seam on the right arm.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a surgical procedure at the user facility, the gown split at the seam on the right arm.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLYTE SURGICOOL TOGA, 2XL, 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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key9694377
MDR Text Key178589387
Report Number0001811755-2020-00450
Device Sequence Number1
Product Code FYA
UDI-Device Identifier37613327117142
UDI-Public37613327117142
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,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408841000
Device Lot Number19091852
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2020
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
-
-