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

Model Number FGA22100 0000

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The end-user went to a fair about 6 months ago and was walking on gravel when the screw that holds the left back lower leg on came out and immediately after that the leg came off and she fell and broke her foot.

Event Description

The device was returned and it was found one of the rear leg tubings was cracked/broken at the metal sleeve that slides into the upper frame.

• 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 guangdong, ; CH
• MDR Report Key: 7483795
• MDR Text Key: 107252478
• Report Number: 3012316249-2018-00026
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22100 0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 05/03/2018
• Distributor Facility Aware Date: 04/16/2018
• Device Age: 14 MO
• Event Location: Other
• Date Report to Manufacturer: 05/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 125