MAUDE Adverse Event Report: VALENTINE INTERNATIONAL LTD CAREX; ROLLING WALKER

Model Number FGA22200 0000

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pneumonia (2011)

Event Date 11/07/2017

Event Type  Injury  

Event Description

The end-user sat down on her rolling walker and the right front (while using) wheel broke at the bolt into the frame sending her to the ground and fracturing her shoulder.The end-user was in rehab for a few months.While at the hospital, she caught the flu and pneumonia.The end-user is now in hospice care.

• Brand Name: CAREX
• Type of Device: ROLLING WALKER
• Manufacturer (Section D): VALENTINE INTERNATIONAL LTD; 8th floor, no. 149 sec. 2 ta t; 221 hsichih city; taipei hsien, taiwan, roc, ; TW
• MDR Report Key: 7299753
• MDR Text Key: 101058473
• Report Number: 3012316249-2018-00007
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/27/2018

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: FGA22200 0000
• Device Catalogue Number: A222-00
• 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: 02/27/2018
• Distributor Facility Aware Date: 02/05/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 02/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 93 YR
• Patient Weight: 45