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

Model Number FGA22100 0000

Device Problems Collapse (1099); Defective Device (2588)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/22/2017

Event Type  Injury  

Event Description

This complaint was reported from a law firm.The law firm states that the end-user sustained personal injuries as a result of a defective rollator.While the end-user was using the rollator, it completely collapsed, causing her to fall to the ground.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, ; CH
• MDR Report Key: 7080992
• MDR Text Key: 93684222
• Report Number: 3012316249-2017-00135
• 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
• Report Date: 12/04/2017

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?: 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: 12/04/2017
• Distributor Facility Aware Date: 11/09/2017
• Event Location: Other
• Date Report to Manufacturer: 12/04/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other