MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP CLASSIC; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number TP650

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 01/24/2017

Event Type  Injury  

Event Description

It was alleged that a patient received burns during use of the device.It was alleged that the user facility wound care specialist inspected the wound and identified blistering and determined that it was a 2nd degree burn.It was alleged that no surgical intervention was needed and that the patient received cream and bandages for the treatment of the alleged burn.

Manufacturer Narrative

The cause of this event could not be confirmed as the device was not returned for evaluation.The user facility was advised that patient skin condition should be checked every 30 minutes as per the operators manual.The device was not returned.

Event Description

It was alleged that a patient received burns during use of the device.It was alleged that the user facility wound care specialist inspected the wound and identified blistering and determined that it was a 2nd degree burn.It was alleged that no surgical intervention was needed and that the patient received cream and bandages for the treatment of the alleged burn.

• Brand Name: CAPITAL TEMP PUMP CLASSIC
• 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 Key: 6350750
• MDR Text Key: 68088142
• Report Number: 0001831750-2017-00045
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: TP650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1