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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 Problem Excessive Heating (4030)
Patient Problem Burn(s) (1757)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
Device could not be identified.
 
Event Description
It was alleged that the patient was on a mul-t-blanket attached to the meditherm iii.The patient had a sheet and a shoulder roll between them and the blanket.The machine was set to 39 degrees c in manual mode.Approx 24 hrs later, it was noted that the patient had what appeared to be a mechanical burn in the pattern of the mul-t blanket on their back between the scapula.The area was treated with silvadene.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
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 Key9786441
MDR Text Key182024790
Report Number0001831750-2020-00307
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
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? No
Date Manufacturer Received02/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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