*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-30 for * manufactured by *.

Event Text Entries

[303499] During root canal procedure the endodontist used a "rubber dam". This involves clamps on teeth and a rubber barrier in the back of the throat. Pt described their past history of claustrophogia. He told pt that he would be with them the entire time, and if pt was unable to handle it he could finish the procedure without it. He told pt he would keep talking to distract them. After approx. 40 minutes he became distracted told pt he needed to speak to his accountant. He left the room. Within a moment the dental assistant also left. Pt's mouth was forced open with clamps, the rubber making speaking difficult. The chair was in a reclined position, with the head lowered. The instrument table remained over pt's lap. Pt had no call light. No alternative method to contact staff for assistance. For greater than 25 minutes, a large clock was at the end of the chair. Pt was left alone. No one came to check on them. Pt began to feel that the rubber was being inhaled deeper and deeper into their throat. Pt became frightened and gradually more claustrophogic. Time passed and pt panicked. Unable to figure out any other method. Pt pushed the tray away, slid forward to lift the rubber from the back of their throat. It was deep enough that pt had to stick their finger down their throat to lift it. To do this pt learned their head forward. Staff came to the room. They were very kind. However, in the follow-up they were not. Within 12 hours pt was attempting to get seen. Facial swelling, severe pain, crepitus from their ear to nose, jaw popping, teeth off track etc. Pt was referred to oral surgeon. Mri revealed bilateral jaw dislocation. In the last three years pt has failed all conservation treatment: mouth guard, physical therapy. Arthrocentesis twice. Pt will have open reduction surgery as soon as their doctors can arrange it. A second opinion concurs. Pt's pain is severe. Medication has caused fevers. Anemia, leukopenia and fatigue. There was no safety measure on the clamps. According to pt has no listed safety guidelines for use of the rubber fan. According to their website they have a request for submission of guidelines on use of the "rubber dam". The endodontist used this equipment with known listed side effects of claustrophogia. From use of the rubber dam.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029728
MDR Report Key489901
Date Received2003-09-03
Date of Report2003-09-11
Date of Event2000-06-01
Date Added to Maude2003-10-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameRUBBER DAM - DENTAL EQUIP.
Product CodeEIE
Date Received2003-09-30
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key478634
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2003-09-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.