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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 Erythema (1840)
Event Date 11/25/2014
Event Type  Injury  
Event Description
It was reported that a patient received redness of skin after using the meditherm machine.Further information was not provided.
 
Event Description
It was reported that a patient received redness of skin after using the meditherm machine.Further information was not provided.
 
Manufacturer Narrative
The investigation confirmed that this device was a concomitant product as the mta7900 was not alleged to have malfunctioned and was only present at the time of the alleged event.No device failure.
 
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Brand Name
MEDI-THERM
Type of Device
SYSTEM, 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 Key4338902
MDR Text Key5139283
Report Number0001831750-2014-03422
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 Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMTA7900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2014
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
Patient Sequence Number1
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