MAUDE Adverse Event Report: CAREX BATH & SHOWER SEAT WITH BACK

Model Number FGB65877 0000

Device Problems Unstable (1667); Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 02/07/2017

Event Type  Injury  

Event Description

The end-user's son called compass health brands to report this event - the son states his father was in the shower using the shower seat without the back on.The end-user (father) was leaning his back against the wall with the legs on the ground, and the legs broke and the chair came apart.The end-user fell and his son called 911.The end-user is reported as now being in the er with congestive heart failure, which is not caused from the fall, but he did seek medical attention because of the fall.The son did not want to provide any other information other than he is going to do something about this, but is not sure what yet.This event had occurred in the end-user's son's home, and the device is reported as having been used a few times for one week.The end-user is reported as having been supervised/assisted at the time of the malfunction, the event occurring in a tile-surfaced stand-up shower.Regular weekly maintenance is reported as having occurred on the device & its snap buttons are reported as having been securely locked into position.The device had already been returned to the store it was bought from for a refund.

• Brand Name: CAREX BATH & SHOWER SEAT WITH BACK
• Type of Device: SHOWER SEAT
• MDR Report Key: 6376534
• MDR Text Key: 69014898
• Report Number: 3012316249-2017-00021
• Device Sequence Number: 1
• Product Code: ILS
• 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: 03/03/2017

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: FGB65877 0000
• Device Catalogue Number: B658-77
• Device Lot Number: N/A
• 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: 03/03/2017
• Distributor Facility Aware Date: 02/07/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2017
• 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: 73 YR
• Patient Weight: 127