MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. RED DOT CRUTCHES

Device Problem Device Slipped (1584)

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

Event Date 12/18/2019

Event Type  malfunction  

Event Description

Patient being treated on an outpatient basis was given a set of crutches from medline rated for up to 300lbs (patient ways less than 300lbs [believe just over 200lbs]).The medline crutches have a plastic c clamps which locks the crutches after height adjustments have been made.Reported c-clamp did not hold and almost caused the patient to fall (but no fall occurred or was reported as occurring).

• Brand Name: RED DOT CRUTCHES
• Type of Device: CRUTCH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9829078
• MDR Text Key: 183272327
• Report Number: 9829078
• Device Sequence Number: 1
• Product Code: INP
• 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: 02/12/2020

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Event Location: Home
• Date Report to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1