WHEELCHAIR ACCESSORY 2478445 110308

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-13 for WHEELCHAIR ACCESSORY 2478445 110308 manufactured by H Fine And Son Ltd..

Event Text Entries

[63098712] As per importer's mdr: mdr decision date: (b)(6) 2012. On (b)(6) 2012 - seh. No serious injury alleged. Malfunction alleged. Per dealer, letting go at the seam where straps attach. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004859134-2013-00002
• MDR Report Key: 6189033
• Date Received: 2013-06-13
• Date of Report: 2013-06-13
• Date Mfgr Received: 2013-06-06
• Date Added to Maude: 2016-12-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR KEVIN WALLS
• Manufacturer Street: 333 GOLDEN EAGLE LANE
• Manufacturer City: LITTLETON CO 80127
• Manufacturer Country: US
• Manufacturer Postal: 80127
• Manufacturer Phone: 7609625412
• Manufacturer G1: H FINE AND SON LTD.
• Manufacturer Street: 93 MANOR FARM RD.
• Manufacturer City: WEMBLEY, MIDDLESEX HAO 1XB
• Manufacturer Country: UK
• Manufacturer Postal Code: HAO 1XB
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: WHEELCHAIR ACCESSORY
• Generic Name: WHEELCHAIR ACCESSORY
• Product Code: KNO
• Date Received: 2013-06-13
• Model Number: 2478445
• Catalog Number: 110308
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: H FINE AND SON LTD.
• Manufacturer Address: 93 MANOR FARM RD. WEMBLEY, MIDDLESEX HAO 1XB UK HAO 1XB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-06-13