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

Catalog Number TP700

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/09/2019

Event Type  Injury  

Event Description

It was reported that the patient complained of lower back pain.The cna's allegedly observed 1st degree and 2nd degree burns on patient from pads.It was reported that the patient was overweight, and unable to turn in the bed, nothing was placed in between the patient and the pad.

Manufacturer Narrative

When the patient involved returned home, the patients family called in to report blisters reportedly from t-pump pads.The patient was advised to come back to emergency department, but no further action was taken by the patient.Device not returned.

Event Description

It was reported that the patient had blisters reportedly from the pads.Further information was not provided.

• 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 Key: 8866567
• MDR Text Key: 153504466
• Report Number: 0001831750-2019-00891
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2019
• 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 Number: 1