MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. FOLDING PADDLE WALKER; WALKER, MECHANICAL

Catalog Number MDS86410KDBW

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2018

Event Type  malfunction  

Event Description

Walker noted to be malfunctioning prior to patient use.Right support on walker will not lock into place which could result in a patient falling.

• Brand Name: FOLDING PADDLE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 8248184
• MDR Text Key: 133090846
• Report Number: 8248184
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MDS86410KDBW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1