HEATING UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-19 for HEATING UNIT manufactured by Check Corporation.

Event Text Entries

[31938597] A (b)(6) y/o female receiving a blood transfusion was sitting in a recliner chair with a pillow behind her back. The chair was equipped with a massager and heating unit. Pt was testing, when she started to feel hot. Her husband was with her during the transfusion. When she sat forward, she noticed smoke coming from the pillow. Husband helped her to stand up and get out of the chair. He exited the room stating "the chair is on fire! " she was assessed by 2 providers immediately. A 20cm x 20cm area on her back was reddened. Silvadene was prescribed, with orders to apply 2 times daily, topically. Assessment by wound care doctor on the following day found a dorsal trunk burn, reportedly a second-degree, however no longer has any erythema or irritation, and certainly no skin loss or blistering. This was likely a first-degree irrigation/burn and she will simply moisturize daily for a few days and then prn. Pt will f/u with wound care doctors as needed. Dates of use: 2. 5 years. Reason for use: chairs used by pts at cancer clinic receiving chemo.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5058010
• MDR Report Key: 5243431
• Date Received: 2015-11-19
• Date of Report: 2015-11-19
• Date of Event: 2015-11-12
• Date Added to Maude: 2015-11-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEATING UNIT
• Generic Name: HEATING UNIT
• Product Code: IRQ
• Date Received: 2015-11-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHECK CORPORATION
• Manufacturer Address: TROY MI 48083 US 48083

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-11-19