THERMA CARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-19 for THERMA CARE * manufactured by Proctor & Gamble.

Event Text Entries

[252943] Recieved 2nd degree burns while using therma care belt on lower back, while using therma care belt according to instructions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026807
• MDR Report Key: 429046
• Date Received: 2002-11-19
• Date of Report: 2002-08-14
• Date of Event: 2002-08-09
• Date Added to Maude: 2002-11-26
• Event Key: 0
• Report Source Code: Voluntary 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: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERMA CARE
• Generic Name: THERAPEUTIC HEAT WRAP 8 HR.
• Product Code: IMA
• Date Received: 2002-11-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2004-02-01
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 418051
• Manufacturer: PROCTOR & GAMBLE
• Manufacturer Address: PO BOX 599 CINCINNATI OH 45201 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-11-19