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

Catalog Number	ITEM CODE: WRX276741V1
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Pain (1994); Vertigo (2134)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, while walking, the right-sided handle of the walker broke, the device "collapsed," and the end-user experienced a fall onto asphalt.The end-user went to a local hospital's emergency department (ed) after the fall incident.A ct scan was performed and according to the end-user, no "brain bleeding" was identified.No further diagnostic exams were reported to the manufacturer.The end-user was medicated with toradol for pain control, bandaged, and discharged home from the ed.The end-user has reportedly experienced vertigo and bruising to his arms, face, scalp, and eyes.The end-user followed-up with his primary care physician who reportedly performed a full neurological exam, with no acute findings reported, and prescribed the end-user antivert.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention, 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 the right-sided handle of the walker broke, the device "collapsed," and the end-user experienced a fall.

• Common Device Name: WALKER, BLUE, FOLDING, W/WHEELS, WAGS PL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9568790
• Report Number: 1417592-2019-00236
• Device Sequence Number: 14043921
• Product Code: ITJ
• UDI-Device Identifier: 00311917158938
• UDI-Public: 00311917158938
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/09/2020

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: ITEM CODE: WRX276741V1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/09/2020
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 132