BRUNO ELECTRA-RIDE II SRE-1540 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-10-19 for BRUNO ELECTRA-RIDE II SRE-1540 * manufactured by Bruno Independent Living Aids.

MAUDE Entry Details

• Report Number: 8010440-2006-00010
• MDR Report Key: 808508
• Report Source: 08
• Date Received: 2006-10-19
• Date of Report: 2006-09-22
• Date of Event: 2006-09-22
• Date Mfgr Received: 2006-09-22
• Device Manufacturer Date: 2002-03-01
• Date Added to Maude: 2007-01-26
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: TERRY ANDRUS
• Manufacturer Street: 1780 EXECUTIVE DRIVE PO BOX 84
• Manufacturer City: OCONOMOWOC WI 53066
• Manufacturer Country: US
• Manufacturer Postal: 53066
• Manufacturer Phone: 2625674990
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BRUNO ELECTRA-RIDE II
• Generic Name: INCLINED STAIRWAY ELEVATOR
• Product Code: ILK
• Date Received: 2006-10-19
• Model Number: SRE-1540
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 795989
• Manufacturer: BRUNO INDEPENDENT LIVING AIDS
• Manufacturer Address: * OCONOMOWOC WI * US
• Baseline Brand Name: BRUNO ELECTRA-RIDE II
• Baseline Generic Name: INCLINED STAIRWAY ELEVATOR
• Baseline Model No: SRE-1540
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-10-19