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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0940000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 09/21/2015
Event Type  Malfunction  
Manufacturer Narrative

The device has been received at the manufacturer for testing. An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

 
Event Description

It was reported that a patient was cut while during a cast-removal procedure at the user facility. Additional information regarding any treatment the patient required due to the event have been requested. If additional information regarding the event becomes available, it will be included in a follow-up report.

 
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Brand NameCAST CUTTER
Type of DeviceSAW, POWERED, AND ACCESSORIES
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 Key5161807
MDR Text Key28752743
Report Number0001811755-2015-03848
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0940000000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2015
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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