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U.S. Department of Health and Human Services

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

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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number UNK_INS
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Abrasion (1689)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
The device is not being returned for evaluation.
 
Event Description
It was reported that during a removal of a cast, the cast cutter blade cut the skin of the patient. Although requested, no information was available regarding adverse consequences, surgical delay or medical intervention at this time.
 
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Brand NameUNKNOWN_INSTRUMENTS_PRODUCT
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7933767
MDR Text Key122651457
Report Number0001811755-2018-01718
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
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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