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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MISTRAL-AIR BLOWER, SYK SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO MISTRAL-AIR BLOWER, SYK SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MA1200-PM
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Burn(s) (1757); Insufficient Information (4580)
Event Date 11/15/2021
Event Type  malfunction  
Event Description
It was reported that a patient received a thermal injury to their left posterior forearm while using a mistral air underbody blanket. The catalog number and serial number of the device have not yet been provided. Additionally, further details regarding the event, injury, and treatment have not yet been provided. Attempts are being made to gather additional details from the user facility.
 
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Brand NameMISTRAL-AIR BLOWER, SYK
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
TSCI BV DBA THE 37COMPANY
beeldschermweg 6f
ah amersfoort 03821
NL 03821
Manufacturer Contact
melanie shepard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key12911413
MDR Text Key282495409
Report Number3003312341-2021-00010
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 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberMA1200-PM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? No
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: 12/01/2021 Patient Sequence Number: 1
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