MAUDE Adverse Event Report: COMBO(ZHONGSHAN)MEDICAL EQUIPMENT MCKESSON BRAND; WALKER, ROLLATOR DURA FOLDING STEEL W/7.5" WHLS RED 300LB

Catalog Number	146-10257RD-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falling while using the walker and explained that the incident occurred after she stood up following a meal, causing her to fall into a window frame.She stated she was fortunate not to be injured.Upon inspection, the front wheel of the walker was found to be completely detached.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRAND
• Common Device Name: WALKER, ROLLATOR DURA FOLDING STEEL W/7.5" WHLS RED 300LB
• Manufacturer (Section D): COMBO(ZHONGSHAN)MEDICAL EQUIPMENT; no.6 tongxing east road, dongs; zhongshan; guangdong, 52841 4; CH 528414
• MDR Report Key: 22736322
• Report Number: 1451040-2025-00064
• Device Sequence Number: 9240423
• Product Code: ITJ
• UDI-Device Identifier: 00612479223141
• UDI-Public: 612479223141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025
• Report Date (Section F): 08/07/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 146-10257RD-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2025
• Device Age: 12 MO
• Event Location: Home
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/07/2025