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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-16 for * manufactured by Metro Medical Equipment, Inc..

Event Text Entries

[468207] Patient found on floor. Patient stated she was trying to get into bed. Wheelchair locked at this time and flipped forward onto anti-tip bars. No injury or complaint of pain. The device broke when it hit the floor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 687614
• MDR Report Key: 687614
• Date Received: 2006-02-16
• Date of Report: 2006-02-16
• Date of Event: 2005-09-02
• Report Date: 2006-02-16
• Date Reported to FDA: 2006-02-16
• Date Added to Maude: 2006-03-17
• 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: RISK MANAGER
• 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: *
• Generic Name: AMPUTEE LEG BOARD
• Product Code: KNO
• Date Received: 2006-02-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 676821
• Manufacturer: METRO MEDICAL EQUIPMENT, INC.
• Manufacturer Address: 12985 WAYNE RD. LIVONIA MI 48150 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-02-16