MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN LLC HOTDOG; PATIENT WARMING DEVICE

Model Number WC52

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 02/24/2016

Event Type  Injury  

Event Description

Patient sustained burns to the forearms, hands, left hip and right flank while under the hotdog device.Patient was undergoing urgent cabg x3 vessels.While warming device being used, patient sustained burns to both arms, hands, left hip and right flank requiring treatment by plastic surgeon.Mfr ref# 3005857264-2016-00001.

• Brand Name: HOTDOG
• Type of Device: PATIENT WARMING DEVICE
• Manufacturer (Section D): AUGUSTINE BIOMEDICAL & DESIGN LLC; eden prairie MN
• MDR Report Key: 5547832
• MDR Text Key: 41958880
• Report Number: 5547832
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WC52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2016
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 124