MAUDE Adverse Event Report: MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING; WALKER

Model Number 10210

Device Problems Vibration (1674); Defective Component (2292); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

A patient was delivered a walker and the walker was noticed to be faulty.The holes in the front leg of the walker were not drilled straight.The holes are angled causing the walker to vibrate and bounce when rolled on hard flooring.All the walkers in the hospital inventory were observed to have the same defect.All of the defective walkers were taken out of our stock.The vendor that we buy the walkers through supplied replacements to each site.

• Type of Device: WALKER
• Manufacturer (Section D): MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING; 99 seaview boulevard; port washington NY 11050
• MDR Report Key: 4861650
• MDR Text Key: 18787928
• Report Number: 4861650
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 10210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2015
• Patient Sequence Number: 1