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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 Problems Burn(s) (1757); Skin Irritation (2076)
Event Date 04/18/2017
Event Type  Injury  
Event Description
It was alleged that the patient received "freezer burn" like spots on their back during treatment. It was alleged that the patient was turned every two hours. The patient was treated with cream applied to the affected area after the treatment was stopped.
 
Manufacturer Narrative
The customer reported that they have not been able to find any defects with the device. It was identified that a possible cause for this issue could be use error (not checking patient skin condition or not keeping skin dry). The account manager has offered to provide additional training to the users.
 
Event Description
It was alleged that the patient received "freezer burn" like spots on their back during treatment. It was alleged that the patient was turned every two hours. The patient was treated with cream applied to the affected area after the treatment was stopped.
 
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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 Key6593547
MDR Text Key76031162
Report Number0001831750-2017-00208
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 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2017
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 Received04/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/03/2009
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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