* UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-05 for * UNK manufactured by *.

Event Text Entries

[304290] Pt was referred by their regular dentist to have a root canal done for chronic abscess in 2000. Pt came out with a traumatic dislocation of the jaw, which was confirmed by an mri. Upon review it was thought that it would heal on its own. A mouth plate was introduced in november 2000 but had to stop after 6 months because it did not help. In 2001 and 2003 needles wre put in the jaw to manipulate it back to position but there was no relief. They were asked to see a physical therapist but there has been no improvement. The root canal had been re-done during which a tooth got broken and had to be crowned. They have scars on their face and have been on pain medication (tegretol).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029448
• MDR Report Key: 483020
• Date Received: 2003-09-05
• Date of Report: 2003-09-05
• Date of Event: 2000-06-06
• Date Added to Maude: 2003-09-15
• 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: *
• Generic Name: RUBBER DAM
• Product Code: EIE
• Date Received: 2003-09-05
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 471906
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-09-05