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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO MEDI-THERM THERMAL REGULATING SYSTEM Back to Search Results
Catalog Number MTA7900
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
It was reported that while in use on high temperature mode, the unit overheated, causing the patient to be burned. No information has been provided regarding the severity or treatment of the injury. Attempts have been made to reach the customer for more information, however they have not responded to these attempts.
 
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Brand NameMEDI-THERM
Type of DeviceTHERMAL REGULATING SYSTEM
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
melanie shepard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key10749565
MDR Text Key213495135
Report Number0001831750-2020-01190
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/28/2020 Patient Sequence Number: 1
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