THERMACARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-03 for THERMACARE * manufactured by *.

Event Text Entries

[276992] Pt placed a large therma care therapeutic heat wrap on lumbar region at 1:00 pm and removed it at 7:00 pm. Despite noting only some mild irritation at the site of the wrap, it revealed three approx 1. 5 cm burns in the left perilumbar region. Pt believes the product may have "leaked".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024972
• MDR Report Key: 393507
• Date Received: 2002-05-03
• Date of Report: 2002-05-03
• Date of Event: 2002-04-26
• Date Added to Maude: 2002-05-14
• 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
• 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: THERMACARE
• Generic Name: XL BACK WRAP THERAPEUTIC HEAT WRAP
• Product Code: IMA
• Date Received: 2002-05-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 382529
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-05-03