INVACARE TREXWD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-13 for INVACARE TREXWD * manufactured by Invacare Health Care.

Event Text Entries

[184191] Resident was being transferred from bed to wheelchair. Obtained a deep laceration approx. 11cm in length on left lower leg. Incident was thought to be the result of a sharp area on the bottom of footrest on the wheelchair.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 245860
• MDR Report Key: 245860
• Date Received: 1999-10-13
• Date of Report: 1999-10-12
• Date of Event: 1999-10-03
• Date Facility Aware: 1999-10-03
• Report Date: 1999-10-12
• Date Reported to FDA: 1999-10-12
• Date Reported to Mfgr: 1999-10-12
• Date Added to Maude: 1999-10-26
• 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

• Brand Name: INVACARE
• Generic Name: WHEELCHAIR FOOTREST
• Product Code: IMM
• Date Received: 1999-10-13
• Returned To Mfg: 1999-10-12
• Model Number: TREXWD
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 8 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 238202
• Manufacturer: INVACARE HEALTH CARE
• Manufacturer Address: 739 GODDARD AVE. CHESTERFIELD MO 63005 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-10-13