THERMAL CARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-25 for THERMAL CARE * manufactured by Procter & Gamble.

Event Text Entries

[250718] Placed thermal care heat wrap on lower back and it gave pt second degree burns. Went to hosp for back pain and burn treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025681
• MDR Report Key: 407735
• Date Received: 2002-07-25
• Date of Report: 2002-07-25
• Date of Event: 2002-06-20
• Date Added to Maude: 2002-07-31
• 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: THERMAL CARE
• Generic Name: THERAPEUTIC HEATWRAPS
• Product Code: IMA
• Date Received: 2002-07-25
• Model Number: *
• Catalog Number: *
• Lot Number: 1097U018B
• ID Number: *
• Device Expiration Date: 2004-03-01
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 396718
• Manufacturer: PROCTER & GAMBLE
• Manufacturer Address: * CINCINNATI OH 45202 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2002-07-25