KODAK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-20 for KODAK manufactured by Kodak.

Event Text Entries

[899497] Patient scheduled to have two upper left and right, and the lower right wisdom teeth extracted under moderate sedation. The film based radiograph was oriented incorrectly on the view which resulted in the surgical exploration of the wrong area. Uf-uncontrollable factors film-based panoramic film must be inverted on the view box to be oriented correctly. The panoramic film is marked with an "l" or "r" in the appropriate corner, when the film is properly placed on the view box, the "l" and "r" are backwards. This has been accepted as an industry norm by the professional dental community and has been addressed through continual training and ensuring compliance with universal protocol requirements. Could the words -front- be placed on the film or the "l" and "r" be universally changed, so that it is logical to the user? Diagnosis or reason for use: x-rays for wisdom teeth extraction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5007507
• MDR Report Key: 1069170
• Date Received: 2008-06-20
• Date of Report: 2008-06-20
• Date of Event: 2007-10-23
• Date Added to Maude: 2008-07-10
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KODAK
• Generic Name: E SPEED PANORAMIC FILM
• Product Code: IXW
• Date Received: 2008-06-20
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1037698
• Manufacturer: KODAK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2008-06-20