*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-12 for * manufactured by Miltex Instrument Co., Inc..

Event Text Entries

[16756020] Pt with cerebral palsy and scoliosis was being sedated in preparation for some dental work. The pt moved, resulting in the displacement of the molt mouth prop. The pt, subsequently, bit down on the dental mirror, which resulted in the dental mirror breaking off of the shaft and handle at the solder joint. The dental mirror became lodged in the pt's throat. Chest x-ray revealed that the mirror was lodged in the esophagus at the level of the aortic knob. The dental mirror was removed in the or.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 196893
• MDR Report Key: 196893
• Date Received: 1998-11-12
• Date of Report: 1998-11-09
• Date of Event: 1998-09-23
• Date Facility Aware: 1998-11-03
• Report Date: 1998-11-09
• Date Reported to Mfgr: 1998-11-09
• Date Added to Maude: 1998-11-17
• 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: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• 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: DENTAL MIRROR
• Product Code: EAX
• Date Received: 1998-11-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 191300
• Manufacturer: MILTEX INSTRUMENT CO., INC.
• Manufacturer Address: 6 OHIO DR. LAKE SUCCESS NY 110420006 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-11-12