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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Catalog Number TP700
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/05/2017
Event Type  Injury  
Event Description
It was alleged that a user may have received a burn while using the device, however the user facility could not confirm if the burn was actually caused by the device.
 
Manufacturer Narrative
Further information on the alleged incident could not be obtained.Device not returned.
 
Event Description
It was alleged that a user may have received a burn while using the device, however the user facility could not confirm if the burn was actually caused by the device.
 
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Brand Name
CAPITAL TEMP PUMP PROFESSIONAL
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
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 Key6663036
MDR Text Key78269080
Report Number0001831750-2017-00265
Device Sequence Number1
Product Code ILO
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,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberTP700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/20/2015
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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