MOUTHPIECE BAR BLOCK UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-16 for MOUTHPIECE BAR BLOCK UNKNOWN manufactured by Unknown.

Event Text Entries

[15378777] Anesthesiologist let bar block slip during seizures. Results from his negligence have been severe laceration of tongue that day and the following tooth problems; 4 root canals, 6 crowns, 2 extractions, 2 implants with the possibility of two more down the line, tmj syndrome, severe migraine headaches, and pain and suffering from all dental procedures. Rptr also developed thrush because he had to take antibiotics with every dental procedure. His depression has worsened since 11/26/93 as a result of the pain and suffering and he is experiencing suicidal ideation to this day 1/19/96.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1008375
MDR Report Key	30318
Date Received	1996-02-16
Date of Report	1996-01-19
Date of Event	1993-11-26
Date Added to Maude	1996-02-22
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	MOUTHPIECE BAR BLOCK
Generic Name	MOUTHPIECE, BREATHING
Product Code	BYP
Date Received	1996-02-16
Model Number	UNKNOWN
Catalog Number	UNKNOWN
Lot Number	UNKNOWN
ID Number	UNKNOWN
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Implant Flag	N
Date Removed	B
Device Sequence No	1
Device Event Key	31400
Manufacturer	UNKNOWN
Manufacturer Address	*

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit	1996-02-16