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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 TOGA, ZIPPER, LARGE/EXTRA LARGE"; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 TOGA, ZIPPER, LARGE/EXTRA LARGE"; GOWN, SURGICAL Back to Search Results
Catalog Number 0400820000
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2015
Event Type  malfunction  
Manufacturer Narrative
Failure analysis is still in progress.
 
Event Description
It was reported that during a surgical procedure at the user facility a seam was torn in the hood.Back-up equipment was used to complete the procedure.No clinically significant delay, no adverse consequences and no medical intervention were reported.
 
Manufacturer Narrative
The product was scrapped by stryker.
 
Event Description
It was reported that during a surgical procedure at the user facility a seam was torn in the hood.Back-up equipment was used to complete the procedure.No clinically significant delay, no adverse consequences and no medical intervention were reported.
 
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Brand Name
T4 TOGA, ZIPPER, LARGE/EXTRA LARGE"
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5092194
MDR Text Key26357880
Report Number0001811755-2015-03476
Device Sequence Number1
Product Code FYA
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Report Date 08/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400820000
Device Lot Number15030562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/30/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2015
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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