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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 11/26/2018
Event Type  Injury  
Event Description
It was alleged by the user facility that the product gave the patient burns from direct contact with pad.It was reported that the patient was elderly and their skin potentially could have been degraded.
 
Manufacturer Narrative
Multiple attempts to contact the customer were made but no response was received.Device not returned.
 
Event Description
It was alleged by the user facility that the product gave the patient burns from direct contact with pad.It was reported that the patient was elderly and their skin potentially could have been degraded.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was alleged by the user facility that the product gave the patient burns from direct contact with pad.It was reported that the patient was elderly and their skin potentially could have been degraded.
 
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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 Key8176011
MDR Text Key130768710
Report Number0001831750-2018-01453
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,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
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? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/26/2018
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 Sequence Number1
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