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

Catalog Number TP700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/06/2017

Event Type  Injury  

Event Description

It was reported that a patient was lying on a temperature therapy pad a developed redness and blisters on their skin.No malfunction was alleged with the product, and no medical intervention was reported.

Manufacturer Narrative

The unit was not evaluated as the customer is not alleging any defect with the unit.Further, the customer contact was unable to give additional details regarding any possible medical intervention.

Event Description

It was reported that a patient was lying on a temperature therapy pad a developed redness and blisters on their skin.No malfunction was alleged with the product, and no medical intervention was reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that a patient was lying on a temperature therapy pad a developed redness and blisters on their skin.No malfunction was alleged with the product, and no medical intervention was reported.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6457348
• MDR Text Key: 71679103
• Report Number: 0001831750-2017-00100
• 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,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• 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: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2013
• 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