CHATTANOOGA BALANCE SYSTEM DYNAMIC BALANCE MACHINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-10 for CHATTANOOGA BALANCE SYSTEM DYNAMIC BALANCE MACHINE * manufactured by Chattanooga Corp..

Event Text Entries

[112199] Pt was being tested on the balance machine, lost his balance and fell backwards (harness was on and secured). Belt gave way at adjuster site. (buckle stayed together).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 137474
• MDR Report Key: 137474
• Date Received: 1997-12-10
• Date of Report: 1997-12-09
• Date of Event: 1997-12-08
• Date Facility Aware: 1997-12-08
• Report Date: 1997-12-09
• Date Reported to Mfgr: 1997-12-08
• Date Added to Maude: 1997-12-12
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CHATTANOOGA BALANCE SYSTEM DYNAMIC BALANCE MACHINE
• Generic Name: BALANCE MACHINE
• Product Code: GWW
• Date Received: 1997-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 134276
• Manufacturer: CHATTANOOGA CORP.
• Manufacturer Address: * CHATTANOOGA TN * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-12-10