QUIKLOK NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-17 for QUIKLOK NI manufactured by Unwin Safety Systems Ltd..

Event Text Entries

[106772] Quiklok wheelchair clamps, designed for use on manual wheelchairs, are incorrectly being used to secure electrically powered wheelchairs, when they are being carried in vehicles. All those involved with the provision of wheelchairs and their carriage in vehicles should be made aware that ratchet type clamps made by unwins safety systems ltd should not be used to secure electrically powered wheelchairs, (unless written permission from unwins, or the wheelchair mfr, has been obtained). It has been reported that powered wheelchairs are being secured in vehicles using the "quiklok" ratchet type clamps, made by unwin safety systems ltd. The mfr is aware of this and has for some time been emphasising to users that the clamps are designed for use with manual wheelchairs only. These clamps are not suitable for use with most powered wheelchairs due to both the increased weight of the wheelchair and the construction of such chairs preventing the clamps from being properly attached to the wheelchair in accordance with the clamp mfrs instructions. Powered wheelchairs should be secured using other more suitable forms of tie-down sys, eg 4 point webbing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002121
• MDR Report Key: 149288
• Date Received: 1998-02-17
• Date of Report: 1998-01-01
• Date Added to Maude: 1998-02-19
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: QUIKLOK
• Generic Name: WHEELCHAIR CLAMPS
• Product Code: KNO
• Date Received: 1998-02-17
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 145481
• Manufacturer: UNWIN SAFETY SYSTEMS LTD.
• Manufacturer Address: WILLOW HOUSE, ARTILLERY ROAD LUFTON TRADING ESTATE, YEOVIL SOMERSET UK BA22 8RP

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-02-17