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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-16 for * manufactured by *.

Event Text Entries

[325462] Dentist installed temporary acrylic crown. Experienced rash 4 days later. Rash led to hives and swelling. Resulting in chemically burnt skin. Layer of skin on hands, arms, and feet peeled off. Primary care dr didn't know what it was, gave pt steroids. Cleared up and came back twice as bad. Allergist never saw anything like it, assumed it was allergic reaction to medicines -diuretic and trazodone-. Returned to dentist 6/2003 and showed him. He said he highly suspected reaction to temporary acrylic crown. He removed temporary crown that day and replaced with permanent one. Improvement in condition began immediately. Still have skin peeling and bowels are still removing toxins.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028723
• MDR Report Key: 467074
• Date Received: 2003-06-16
• Date of Report: 2003-06-16
• Date of Event: 2003-05-09
• Date Added to Maude: 2003-06-24
• 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: *
• Generic Name: ACRYLIC CROWN MATERIALS
• Product Code: ELZ
• Date Received: 2003-06-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 456019
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-06-16