MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD DRIVE (A WALKER); WALKER, MECHANICAL

Model Number R800KD-BL

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

Walker slipped sideways on a patient, almost far enough to come out from under her.The wheels are made of hard plastic which slips easily.The rear wheels have a misalignment, both sides have toe out which forces the wheels to somewhat slip in order for the walker to travel in a straight line.This forced slippage further degrades the already weak grip of the plastic wheels.If the patients weight suddenly shifts, the wheel with more weight will suddenly grip better, and will drag the wheel with less weight on it, dragging it sideways, causing the walker to go side wards on the patient.A sudden weight shift by the patient can be the result of a near trip, near fall, or momentary loss of balance.This is the worst time to have the walker slip.The seat slips sideways.After repositioning it, it slips again.Brand medline.Model drive r800kd-bl.Sn: (b)(6).We are tying to get a warranty replacement but it is hell dealing with insurance companies, providers, and medical marketers.

• Brand Name: DRIVE (A WALKER)
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 17691879
• MDR Text Key: 322929123
• Report Number: MW5145203
• 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: Patient
• Type of Report: Initial
• Report Date: 08/30/2023

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: R800KD-BL
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White