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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL T-PUMP / CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL T-PUMP / CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Model Number TP700
Device Problems Fail-Safe Design Failure (1222); Device Slipped (1584)
Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994)
Event Date 10/12/2016
Event Type  malfunction  
Event Description
The patient requested the application of heat to manage chronic pain and fibromyalgia.A water circulating pump was given to the patient to be used intermittently, independently.The pad of the pump was covered with a pillow case to prevent direct contact with the skin.A few days later, the patient applied the heating pad and woke complaining of pain in her lower back and left arm.When examined by the nurse it was noted that the pillow case had slipped and the heating pad had come in direct contact with the patient's skin causing erythema and a small blister on her elbow.
 
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Brand Name
T-PUMP / CAPITAL TEMP PUMP PROFESSIONAL
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
STRYKER MEDICAL
3800 e. centre ave.
portage MI 49002
MDR Report Key6116521
MDR Text Key60451815
Report Number6116521
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 User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTP700
Device Catalogue NumberTP700
Other Device ID Number40110097
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/31/2016
Event Location Hospital
Date Report to Manufacturer10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; OTHER, IV ANALGESICS
Patient Outcome(s) Other;
Patient Age34 YR
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