THERMACARE L/XL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-12 for THERMACARE L/XL * manufactured by Proctor And Gamble.

Event Text Entries

[21964334] "thermacare" heat wrap was used as indicated on package for 8 hrs. An area of skin sustained a burn. Burn area was the size of two of the discs found in the wrap.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026168
• MDR Report Key: 416759
• Date Received: 2002-09-12
• Date of Report: 2002-09-12
• Date of Event: 2002-09-07
• Date Added to Maude: 2002-09-18
• 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: PHARMACIST
• 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 L/XL
• Generic Name: HEAT WRAP
• Product Code: IMA
• Date Received: 2002-09-12
• Model Number: *
• Catalog Number: *
• Lot Number: 1100U0188
• ID Number: *
• Device Expiration Date: 2004-03-31
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 405803
• Manufacturer: PROCTOR AND GAMBLE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-09-12