MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER,ADULT, BARIATRIC, W/WHEELS, BASIC

Catalog Number MDS86410XWWB

Device Problem Material Twisted/Bent (2981)

Patient Problem Laceration(s) (1946)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported that he was walking with his walker and the back left leg (the one with no wheels) bent above the joint where the leg attached to the unit.The customer reported that he fell to the ground and hit his head when he fell resulting in a laceration above his left eye.(b)(6) called the paramedics and was brought to the local hospital for evaluation and treatment.The ct scan of the head was normal and the customer was given 3 stitches above his left eye prior to discharge.No additional medical intervention was required.The sample was not returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

The back left leg bent resulting in the customer falling on the ground and customer getting a laceration above the left eye.

• Type of Device: WALKER,ADULT, BARIATRIC, W/WHEELS, BASIC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12458122
• MDR Text Key: 270999300
• Report Number: 1417592-2021-00175
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86410XWWB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 125