VISTAS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-04 for VISTAS * manufactured by Vistas, Everest & Jennings.

Event Text Entries

[160615] While transferring her to toilet with two-man assist, suffered laceration to left calf from wheelchair footrest bracket.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 243615
• MDR Report Key: 243615
• Date Received: 1999-10-04
• Date of Report: 1999-09-27
• Date of Event: 1999-09-26
• Date Facility Aware: 1999-09-26
• Report Date: 1999-09-27
• Date Reported to FDA: 1999-10-04
• Date Added to Maude: 1999-10-12
• 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: VISTAS
• Generic Name: WHEELCHAIR, DETACHABLE FOOT RESTS
• Product Code: IMM
• Date Received: 1999-10-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: MERCY #WH0106
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 236004
• Manufacturer: VISTAS, EVEREST & JENNINGS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-10-04