MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. WALKER; TIPS AND PADS, CANE, CRUTCH AND WALKER

Catalog Number MDS86410W5414

Device Problem Misassembled (1398)

Patient Problem Fall (1848)

Event Date 11/26/2017

Event Type  malfunction  

Event Description

Patient was walking into room and fell onto his back.The walker had not been put together properly.The wheels were attached to the back of the walker and the stoppers were on the front.

• Brand Name: WALKER
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7312919
• MDR Text Key: 101501935
• Report Number: 7312919
• Device Sequence Number: 1
• Product Code: INP
• 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: 01/29/2018,01/30/2018

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 Catalogue Number: MDS86410W5414
• Device Lot Number: 88517010016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES.
• Patient Age: 68 YR
• Patient Weight: 110