RADIOGRAPHIC FILM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-26 for RADIOGRAPHIC FILM * manufactured by Eastman Kodak Co..

Event Text Entries

[21769] Nasal surgery done in 4/94. Ent surgeon used x-ray film as nasal splints following surgery which were not removed until one week after surgery. Surgeon says this is a usual procedure but rptr has complete loss of smell.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1009993
• MDR Report Key: 39808
• Date Received: 1996-09-26
• Date of Report: 1996-09-19
• Date Added to Maude: 1996-09-30
• 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: RADIOGRAPHIC FILM
• Generic Name: RADIOGRAPHIC FILM
• Product Code: IWZ
• Date Received: 1996-09-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 40939
• Manufacturer: EASTMAN KODAK CO.
• Manufacturer Address: BLDG 69 7TH FL KODAK PARK ROCHESTER NY 14650 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	1996-09-26