I-CAT 9140 0.830.3196

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-16 for I-CAT 9140 0.830.3196 manufactured by Imaging Sciences International, Llc.

Event Text Entries

[2841330] The i-cat classic button box installed incorrectly, alleged over exposure to radiation.
Patient Sequence No: 1, Text Type: D, B5

[10047746] Investigation in progress, to date no information suggesting serious injuries associated with this incident has been received.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2530069-2012-00018
• MDR Report Key: 2659672
• Report Source: 05
• Date Received: 2012-07-16
• Date of Report: 2012-06-19
• Date of Event: 2012-06-19
• Date Mfgr Received: 2012-06-19
• Device Manufacturer Date: 2006-09-15
• Date Added to Maude: 2012-11-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: ELIZABETH LAZARO
• Manufacturer Street: 1910 NORTH PENN RD.
• Manufacturer City: HATFIELD PA 19440
• Manufacturer Country: US
• Manufacturer Postal: 19440
• Manufacturer Phone: 2679540365
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: I-CAT
• Generic Name: EXTRAORAL X-RAY SYSTEM MUH
• Product Code: MUH
• Date Received: 2012-07-16
• Model Number: 9140
• Catalog Number: 0.830.3196
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IMAGING SCIENCES INTERNATIONAL, LLC
• Manufacturer Address: 1910 NORTH PENN RD. HATFIELD PA 19440 US 19440

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-16