TULIP MEDICAL (VIAVAX) CHI *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-05 for TULIP MEDICAL (VIAVAX) CHI * manufactured by Tulip Medical, Inc..

Event Text Entries

[201373] Pt was instructed to wear a compression garment around face which induced so much pressure on jaw that caused it to shift back and created a severe tmj condition. Due to complications from wearing this garment pt has developed severe headaches, severe neckaches at the back of the skull, severe vertigo, ringing in both ears, severe hearing difficulties, clicking, popping and grinding in the jaw joint, severe difficulty in chewing, severe fatigue of the jaw muscles after chewing or talking, limitations of the range of motion of the lower jaw, locking of the jaw in either the open or closed position, loss of teeth. Pt has consulted a tmj specialist who examined this garment and has confirmed without a doubt that this device was the direct cause of pt's problem. Pt's daily functions, like eating are limited. Pt has been without chewing for 18 months. Pt was not aware of this terrible disorder or that such pressure can cause the mandible to be compressed back into the joint space and can precipitate a tmj condition. In addition, pt is in the process of speaking with the compression garment mfr so that other people can be aware of the complications that this compression garment can cause.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020538
• MDR Report Key: 307781
• Date Received: 2000-12-05
• Date of Report: 2000-11-09
• Date of Event: 1998-08-01
• Date Added to Maude: 2000-12-11
• 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
• 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: TULIP MEDICAL (VIAVAX)
• Generic Name: COMPRESSION GARMENT
• Product Code: KMO
• Date Received: 2000-12-05
• Model Number: CHI
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 297780
• Manufacturer: TULIP MEDICAL, INC.
• Manufacturer Address: 2535 KETTNER BLVD, STE 3A3 SAN DIEGO CA 92101 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit	2000-12-05