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

Catalog Number TP700

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 05/19/2017

Event Type  Injury  

Event Description

It was alleged that the patient was laying on the pad for 6 hours and received a 2nd degree burn on the mid back.It was reported that silvadene cream was applied to treat the effected area.

Manufacturer Narrative

The device was not returned to stryker for further evaluation.

Event Description

It was alleged that the patient was laying on the pad for 6 hours and received a 2nd degree burn on the mid back.It was reported that silvadene cream was applied to treat the effected area.

Manufacturer Narrative

Supplemental submitted to include udi.Device not returned.

Event Description

It was alleged that the patient was laying on the pad for 6 hours and received a 2nd degree burn on the mid back.It was reported that silvadene cream was applied to treat the effected area.

• 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: 6642988
• MDR Text Key: 77629001
• Report Number: 0001831750-2017-00247
• 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: 06/15/2017
• 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: 05/19/2017
• 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