MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH SEAT

Model Number 12022KD-4

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/12/2019

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a bath chair.The device was retrieved by the service provider.Service provider dropped off the chair to the end-user.The next day the end-user sat alone on the chair for 5 minutes.The chair broke causing him to fall.He hurt his back.Patient was initially hospitalized after the fall.He was transferred to a rehabilitation center where he was for 12 days for pain and mobility treatment.

• Brand Name: DRIVE
• Type of Device: BATH SEAT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8682236
• MDR Text Key: 147438877
• Report Number: 2438477-2019-00020
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12022KD-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2019
• Distributor Facility Aware Date: 03/13/2019
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 104