MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GUARDIAN ENVOY 380; WALKER, MECHANICAL

Model Number GO7981TM

Device Problems Defective Component (2292); Failure to Align (2522); Device Fell (4014)

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

Event Date 02/05/2020

Event Type  Injury  

Event Description

We ordered the envoy 380 from healthcare supply from wheel walker vehicle but the screw fell out of the lead wheel making the appliance unusable to my (b)(6) y/o dad.We contacted the mfr and they sent another three wheeler.It was defective too as the back wheels were out of alignment.We contacted the company again and have not gotten anywhere with them over this matter.They do not allow phone conversation, only emails.Fda safety report id#.(b)(4).

• Brand Name: GUARDIAN ENVOY 380
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9799850
• MDR Text Key: 182556271
• Report Number: MW5093555
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GO7981TM
• Device Lot Number: 88519100003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 75