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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number UNK_MED
Device Problems Patient Device Interaction Problem (4001); Excessive Heating (4030)
Patient Problems Abrasion (1689); Skin Discoloration (2074); Blister (4537)
Event Date 03/08/2021
Event Type  Injury  
Event Description
It was reported that the patient has skin abrasions on their back from the cooling blanket being placed underneath them. It was reported that the cooling blanket may have accidentally been programmed to warm the patient instead of cool them. Further information has not been provided.
 
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Brand NameUNKNOWN_MEDICAL_PRODUCT
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 Key11623543
MDR Text Key244208656
Report Number0001831750-2021-00673
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
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_MED
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 Received03/09/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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