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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO OR TOWEL WHITE STRL; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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STRYKER INSTRUMENTS-KALAMAZOO OR TOWEL WHITE STRL; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Catalog Number 0613360020
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer? discarded.
 
Event Description
It was reported that during a surgical procedure at the user facility, the identifier tag separated from one of the towels.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
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Brand Name
OR TOWEL WHITE STRL
Type of Device
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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 Key10212380
MDR Text Key197144717
Report Number0001811755-2020-01607
Device Sequence Number1
Product Code GDY
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
Report Date 06/30/2020
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 Number0613360020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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