MAUDE Adverse Event Report: MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE DRIVE STEERABLE ALUMINIUM KNEE WALKER; WALKER MECHANICAL

Model Number

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

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

Event Date 07/17/2018

Event Type  malfunction  

Event Description

Purchased a drive knee-scooter (mobility device/medical device) from that company; tiller screw, which controls steering of the device, will not hold no matter how lightly secured it is.Handles go one way, front wheels go the other way, making steering the device impossible and use of the device by a disabled person (such as myself) is rendered quite unsafe.This medical device is defective and unsafe.

• Brand Name: DRIVE STEERABLE ALUMINIUM KNEE WALKER
• Type of Device: WALKER MECHANICAL
• Manufacturer (Section D): MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE
• MDR Report Key: 7717937
• MDR Text Key: 115189672
• Report Number: MW5078586
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2018

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: Lay User/Patient

Device Model Number

• Device Catalogue Number: AMAZON LISTING

Device Lot Number

• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 86