ERGOSTYLE ERGOSTYLE FLEXATION 8760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-06-03 for ERGOSTYLE ERGOSTYLE FLEXATION 8760 manufactured by Chattanooga Group / A Div Of Encore Medical L.p..

Event Text Entries

[276619] Lifting motor over-extended causing the treatment table to fall. No consequences to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1022819-2002-00002
• MDR Report Key: 397728
• Report Source: 04
• Date Received: 2002-06-03
• Date Mfgr Received: 2001-08-31
• Device Manufacturer Date: 2001-07-01
• Date Added to Maude: 2002-06-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MICHAEL TREAS
• Manufacturer Street: 4717 ADAMS RD
• Manufacturer City: HIXSON TN 37343
• Manufacturer Country: US
• Manufacturer Postal: 37343
• Manufacturer Phone: 4238707218
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: MA
• Previous Use Code: 3
• Removal Correction Number: #1180
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ERGOSTYLE
• Generic Name: CHIROPRACTIC TREATMENT TABLE
• Product Code: JFB
• Date Received: 2002-06-03
• Model Number: ERGOSTYLE FLEXATION
• Catalog Number: 8760
• Lot Number: *
• ID Number: CORRECTIVE ACTION #1180
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 386775
• Manufacturer: CHATTANOOGA GROUP / A DIV OF ENCORE MEDICAL L.P.
• Manufacturer Address: 4717 ADAMS RD. HIXSON TN 37343 US
• Baseline Brand Name: ERGOSTYLE
• Baseline Generic Name: CHIROPRATIC TREATMENT TABLE
• Baseline Model No: ERGOSTYLE FLEXA
• Baseline Catalog No: 8760
• Baseline ID: CORRECTIVE ACTI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-06-03