* 00712804

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-07 for * 00712804 manufactured by United States Endoscopy Group, Inc..

Event Text Entries

[4878406] We are investigating and trialing a new bite block with a foam element due to three occurrences of dental damage with us endoscopy maxi bite block over past 12 months. One was the dental crown and part of the tooth was spat out after the transesophageal echocardiogram (tee) and cardioversion once the patient woke up. The other two were during removal of the bite block after esophagogastroduodenoscopy (egd) procedures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4029689
• MDR Report Key: 4029689
• Date Received: 2014-08-07
• Date of Report: 2014-08-07
• Date of Event: 2013-11-30
• Report Date: 2014-08-07
• Date Reported to FDA: 2014-08-07
• Date Reported to Mfgr: 2014-08-22
• Date Added to Maude: 2014-08-22
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: ENDOSCOPIC BITE BLOCK
• Product Code: MNK
• Date Received: 2014-08-07
• Model Number: *
• Catalog Number: 00712804
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNITED STATES ENDOSCOPY GROUP, INC.
• Manufacturer Address: 5976 HEISLEY RD MENTOR OH 44060 US 44060

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-08-07