MAUDE Adverse Event Report: CAREX; ROLLATOR

Model Number FGA22200 0000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The customer states that the seat on the rollator always slides side-to-side, and when the end-user went to sit on the seat, she slid, causing her to fall backwards and hit her head and hip.An emt came out and helped her up, but she did not need to go to a doctor.The event is reported as having occurred on a hardwood surface, with the end-user sitting on the device's seat with the loop brake engaged.The device involved with this event was returned to compass health brands and evaluated on 6/30/2017.The customer's complaint could be confirmed from a review of the returned device.The plastic clips that hold the seat to the frame on the rollator appeared to have been loose on the returned device - the screws that hold the plastic clips to the seat were slightly loosened, causing the retention for movement from side-to-side to go down.The plastic seat was also found to be cracked, and starting to bend downward.The upholstery had to be cut on the bottom of the seat in order to verify what was happening.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• MDR Report Key: 6710729
• MDR Text Key: 79950255
• Report Number: 3012316249-2017-00081
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2017

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: FGA22200 0000
• Device Catalogue Number: A222-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2017
• Distributor Facility Aware Date: 06/19/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 81