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

Device Problem Component Missing (2306)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

Reporter wrote, "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.(b)(4).Retailer: (b)(6).Retailer state: (b)(4).Purchase date: 03/01/20 16, this date is an estimate.".

• Brand Name: CAREX
• Type of Device: WALKER
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no, 58 yu long 3 road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer (Section G): AID-PRO HEALTHCARE CO., LTD.; no, 58 yu long 3 road; dong sheng town; zhong shan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 6352267
• MDR Text Key: 68512601
• Report Number: 3012683925-2017-00001
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1