DRIVE MEDICAL 100014 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-02-14 for DRIVE MEDICAL 100014 NA manufactured by Foshan R Poon Medical Products Co, Ltd.

Event Text Entries

[3141069] Drive medical has received a complaint from an end user about an incident involving a replacement walker glide allegedly imported and distributed by (b)(4). It is alleged that the end user was using the drive medical walker glide with a walker made by a different mfr. There was a slit in the rug and the glide went under it causing the claimant to fall over the walker and allegedly broke her left leg. This mdr report is based on the end user complaint.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2438477-2013-00005
• MDR Report Key: 2967623
• Report Source: 99
• Date Received: 2013-02-14
• Date of Report: 2013-01-15
• Date of Event: 2012-12-10
• Date Facility Aware: 2013-01-15
• Report Date: 2013-02-14
• Date Reported to Mfgr: 2013-02-14
• Date Added to Maude: 2013-02-21
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRIVE MEDICAL
• Generic Name: WALKER TIPS
• Product Code: NXE
• Date Received: 2013-02-14
• Model Number: 100014
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FOSHAN R POON MEDICAL PRODUCTS CO, LTD
• Manufacturer Address: FOSHAN 528216 CH 528216

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-02-14