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

Model Number FGA22100 0000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/10/2017

Event Type  Injury  

Event Description

Law firm contacted (b)(4) via letter regarding a consumer who sustained injuries as a result of an accident set forth - letter states that the rollator failed, and caused the consumer to fall and injure himself.

Event Description

New information identified, including device detail & manufacturer information.

• Brand Name: CAREX
• Type of Device: STEEL ROLLING WALKER
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, ; CH
• MDR Report Key: 6985575
• MDR Text Key: 90510402
• Report Number: 3012316249-2017-00127
• 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: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/17/2018,08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22100 0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2018
• Distributor Facility Aware Date: 08/17/2018
• Date Report to Manufacturer: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other