MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; UNKNOWN WALKER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Weakness (2145)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user experienced a fall while using the unknown walker.Reportedly, she fell onto her back and her head and she experienced bruising to her chest.The end-user was taken to a local hospital after this fall.No information was provided regarding diagnostic exams or medical treatment performed at the local hospital.After an unidentified period of time, the end-user was admitted to a rehabilitation center "for over a month." the end-user reports that she has experienced weakness in her legs and difficulty walking since the fall.No additional information was provided to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.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 Description

It was reported that the end-user experienced a fall while using the unknown walker and has had weakness in her legs and difficulty walking.

• Type of Device: UNKNOWN WALKER
• 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: 7868086
• MDR Text Key: 119935053
• Report Number: 1417592-2018-00092
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 91