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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MEDI-THERM SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO MEDI-THERM SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MTA7900
Device Problem Insufficient Information (3190)
Patient Problem Swelling (2091)
Event Date 10/20/2016
Event Type  malfunction  
Event Description
It was reported that a patient received blisters while using the temperature therapy device.
 
Manufacturer Narrative
Further information regarding the alleged event was unable to be obtained and the device was not returned for evaluation.
 
Event Description
It was reported that a patient received blisters while using the temperature therapy device.
 
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Brand NameMEDI-THERM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6112411
MDR Text Key60754157
Report Number0001831750-2016-00350
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMTA7900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
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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