MAUDE Adverse Event Report: MEDLINE CANADA WALKER; WALKER, MECHANICAL

Model Number MDS864104

Device Problem Break (1069)

Patient Problems Erythema (1840); Fall (1848)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The patient ambulated to bathroom with walker along with the aide.The patient was steadying himself with the walker while he was lowering self onto the commode, when the walker broke causing the patient to fall forward onto the floor.Small area of redness to his right cheek status post and no other visible injuries.

• Brand Name: WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE CANADA
• MDR Report Key: 17163505
• MDR Text Key: 317554105
• Report Number: MW5118464
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/13/2023

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 Model Number: MDS864104
• Device Lot Number: C130613714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2023
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White