MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number RTL12203KDR

Device Problem Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

(b)(4) is the initial importer of the device which is a bath shower bench.We have not received the device back for evaluation or additional data from the user or his caregiver.We are filing this report in an overabundance of caution.The legs on the chair bent on the third use.The replacement device's leg bent on the first use.Similar issue was noted in mdr 2018-00061.

• Brand Name: DRIVE
• Type of Device: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8769781
• MDR Text Key: 151366538
• Report Number: 2438477-2019-00029
• 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: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL12203KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Distributor Facility Aware Date: 03/30/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 104