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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 Partial thickness (Second Degree) Burn (2694)
Event Date 12/10/2014
Event Type  Injury  
Event Description
It was reported that the patient received a blister from a burn received during temperature therapy.Further information was not provided.
 
Manufacturer Narrative
A visual and functional inspection was performed by a field service representative who was unable to confirm the alleged defect, as no defects were found during the inspection of the device and the condition of the overheating was unable to be duplicated.
 
Event Description
It was reported that the patient received a blister from a burn received during temperature therapy.Further information was not provided.
 
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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 Key4338915
MDR Text Key5345705
Report Number0001831750-2014-03424
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2014
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 Received12/10/2014
Was Device Evaluated by Manufacturer? Yes
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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