*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-22 for * manufactured by *.

Event Text Entries

[375693] Pt received paraffin treatment to index (left) finger. After 10 minutes of treatment, the pt informed therapist wax was "hotter than usual. " paraffin removed, skin inspected. Next day pt informed therapist they had a blister, pt declined medical treatment. Five days later pt returned to therapy with a fluid filled blister on left index finger. Pt again declined medical treatment. Discharge planning was initiated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034044
• MDR Report Key: 565011
• Date Received: 2004-12-22
• Date of Report: 2004-12-16
• Date of Event: 2004-01-21
• Date Added to Maude: 2005-01-13
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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: *
• Generic Name: PARAFFIN
• Product Code: IMC
• Date Received: 2004-12-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 554780
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-22