MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC GUARDIAN ALUMINUM CRUTCH

Catalog Number MDSV80535

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292); Device Fell (4014)

Patient Problem Injury (2348)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

Employee had sustained an injury to ankle while working and was provided with crutches to use.When employee returned to employee health office, the handle of one of the crutches fell off from the crutch frame, possible due to a defective screw that attached handle to the crutch frame.It was noted that there was not a white plastic washer with the screw that came loose from the crutch frame.Employee did not sustain injury.

• Brand Name: GUARDIAN ALUMINUM CRUTCH
• Type of Device: CRUTCH
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline pl.; mundelein IL 60060
• MDR Report Key: 9238634
• MDR Text Key: 163765796
• Report Number: 9238634
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDSV80535
• Device Lot Number: 6451906000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2019
• Date Report to Manufacturer: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1