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

Catalog Number 10220-2WW

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 08/28/2015

Event Type  malfunction  

Event Description

Bariatric rolling walker rated for 500 lbs.Was being used with (b)(6) patient in the gym.The button for adjusting the height of the rolling walker became disassembled from the spring.Manufacturer response for bariatric rolling walker, bariatric aluminum folding walker, two button (per site reporter): as of this report, no response has been given by the manufacturer.

• 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: 5077312
• MDR Text Key: 25828804
• Report Number: 5077312
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2015,09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 10220-2WW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES USED
• Patient Age: 74 YR
• Patient Weight: 159