MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER, BLUE, FOLDING, W/WHEELS, WAGS PL

Catalog Number	WRX276741V1
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while walking up a handicap access ramp with a rollator, the right handle of the rollator "flew-out" to the right resulting in the end-user experiencing a fall to the ground.The end-user was able to get back to her feet with the assistance of two other individuals (her daughter and neighbor) with no immediate injury noted.Her daughter took the end-user to the emergency room later that day for evaluation.The end-user reports x-rays taken.End-user reports a surface cut to the left leg that required bandaging but no serious injuries.End-user released from the er without further treatment and instructed to follow-up with her primary care physician (pcp).Upon follow-up, the pcp confirmed she had experienced a scaphoid fracture of the right hand with no additional fractures noted.End-user states there is no treatment at this time for a scaphoid fracture.The walker has not been returned to the manufacturer for evaluation as of the date of this report.Due to the reported incident and in an abundance of caution this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that while walking up a handicap access ramp with a rollator, the right handle of the rollator "flew-out" to the right resulting in the end-user experiencing a fall to the ground and a scaphoid fracture.

• Common Device Name: WALKER, BLUE, FOLDING, W/WHEELS, WAGS PL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9707646
• Report Number: 1417592-2020-00006
• Device Sequence Number: 3381280
• Product Code: ITJ
• UDI-Device Identifier: 00311917158938
• UDI-Public: 00311917158938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX276741V1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 67