MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. CAREX; MECHANICAL WALKER

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problems Ecchymosis (1818); Fall (1848)

Event Date 01/10/2017

Event Type  No Answer Provided  

Event Description

My aunt bought a cares mobility step and sit walker and she used it for the first time on (b)(6) 2017 to go to a dr's appointment and found that using the brakes were not working well and took a fall in the hospital hallway as she was leaving her appointment.She was quite bruised up on her right side of her body.She is (b)(6).One of the hospital staff looked for the brake locks and there wasn't any brake locks, he said that was very dangerous not having no way to lock the brakes.I believe for the safety of others that use this particular product that there should be a recall on them.Document number: i1710456a.Report number: 20170120-dddf8-2147407856.Retailer: (b)(6).Retailer state: (b)(4).Purchase date: 03/01/2016, this date is an estimate.

• Brand Name: CAREX
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.
• MDR Report Key: 6307509
• MDR Text Key: 66825407
• Report Number: MW5067700
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR