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

Catalog Number ITEM CODE: WRX276741V1

Device Problems Break (1069); Collapse (1099)

Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994); Vertigo (2134)

Event Date 12/01/2019

Event Type  malfunction  

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 Description

It was reported that the right-sided handle of the walker broke, the device "collapsed," and the end-user experienced a fall.

• Type of Device: WALKER, BLUE, FOLDING, W/WHEELS, WAGS PL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9568790
• MDR Text Key: 190770358
• Report Number: 1417592-2019-00236
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00311917158938
• UDI-Public: 00311917158938
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: ITEM CODE: WRX276741V1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 132