8446K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-01 for 8446K manufactured by Ali Med.

Event Text Entries

[10369] Resident was sitting in wheelchair at rns desk. She was seen to lean forward and fell out of wheelchair, landing on right side on floor. Safety seat belt had been closed according to nursing assistants caring for resident. Seat belt was not closed after fall. Pt had skin tear below right knee. She hit head against rns desk. Neuro checks were done for 3 days. Physician notified of fall and possible injury-protrusion of right knee area. No immediate intervention ordered. Physician visit on 1/19//94 and x-ray ordered. Exam of safety belt after fall revealed that only minimal pressure on release button was needed to release the safety belt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 12299
• MDR Report Key: 12299
• Date Received: 1994-02-01
• Date of Report: 1994-01-28
• Date of Event: 1994-01-17
• Date Facility Aware: 1994-01-17
• Report Date: 1994-01-28
• Date Reported to FDA: 1994-01-28
• Date Added to Maude: 1994-03-29
• 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
• 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

• Generic Name: WHEELCHAIR SAFETY BELT
• Product Code: IQB
• Date Received: 1994-02-01
• Catalog Number: 8446K
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 36 MO
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 12299
• Manufacturer: ALI MED
• Manufacturer Address: DEDHAM MA 02026 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Not Applicable; 2. Death	1994-02-01