* MR 6838069 3938671

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-20 for * MR 6838069 3938671 manufactured by Graham Medical.

Event Text Entries

[298300] Hot water bottle. Vistor requested something for comfort. Visitor given a hot water bottle with machine heated water inside. Site reporter states the staff member poured the hot water into the hot water bottle from the hot water available from the coffee pot which also dispenses hot water. Staff member then covered the hot water bottle with a pillow case. Visitor placed between themselves (on back) and chair and went to sleep. Developed a blistering burn 1st and 2nd degree. Site reporter states there were no instructions or manufacturer recommendations to accompany the hot water bottle as this was a "very old" device described as "the red, rubber" hot water bottles. Since this incident, these hot water bottles are no longer in use and have been removed from the facility. The coffee pots and hot water dispensors are now labeled with stickers stating "not for pt use". The facility's root cause analysis team is continuing to develop policies and protocols for hot and cold devices, such as compresses and warm soaks and staff education continues concerning these policies. Innappropriate use of hot water bottle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 433775
• MDR Report Key: 433775
• Date Received: 2002-12-20
• Date of Report: 2002-03-15
• Date of Event: 2002-01-31
• Report Date: 2002-03-15
• Date Reported to FDA: 2002-03-15
• Date Added to Maude: 2002-12-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: HOT WATER BOTTLE
• Product Code: FPF
• Date Received: 2002-12-20
• Model Number: MR 6838069
• Catalog Number: 3938671
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 422714
• Manufacturer: GRAHAM MEDICAL
• Manufacturer Address: 2273 LARSEN RD P.O. BOX 19100 GREEN BAY WI 543079100 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-12-20