* UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-09 for * UNK manufactured by Ceder Valley.

Event Text Entries

[383222] Physical therapist was going to use over the door unit in a pt with tmj. Pt refused, want to the hosp for the right traction to be used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034620
• MDR Report Key: 572755
• Date Received: 2005-02-09
• Date of Report: 2005-02-09
• Date of Event: 2001-09-11
• Date Added to Maude: 2005-02-16
• 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: 3
• 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: HOLTER TRACTION UNIT
• Product Code: IRS
• Date Received: 2005-02-09
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 562623
• Manufacturer: CEDER VALLEY
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-02-09