WHEELCHAIR ACCESSORY 7740P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-06-14 for WHEELCHAIR ACCESSORY 7740P manufactured by Foshan R. Poon Medical Products Co., Ltd..

Event Text Entries

[6033134] Per importer's mdr: provider states the tube is splitting where the tube bends and meets with the other tube. End-user weighs (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1000282279-2013-00050
• MDR Report Key: 4944970
• Report Source: 08
• Date Received: 2013-06-14
• Date of Report: 2013-06-14
• Date Mfgr Received: 2013-06-10
• Date Added to Maude: 2015-07-29
• 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: 0
• Event Location: 0
• Manufacturer Contact: MR. KEVIN WALLS
• Manufacturer Street: 33 GOLDEN EAGLE LANE
• Manufacturer City: LITTLETON CO 80127
• Manufacturer Country: US
• Manufacturer Postal: 80127
• Manufacturer Phone: 7209625412
• Manufacturer G1: FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
• Manufacturer Street: NEW CITY DISTRICT, DANZAO NANHAI, FOSHAN
• Manufacturer City: GUANGDONG 528216
• Manufacturer Country: CH
• Manufacturer Postal Code: 528216
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WHEELCHAIR ACCESSORY
• Product Code: KNO
• Date Received: 2013-06-14
• Model Number: 7740P
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
• Manufacturer Address: NEW CITY DISTRICT, DANZAO NANHAI, FOSHAN GUANGDONG 528216 CH 528216

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-06-14