MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE MEDICAL BATH SEAT W/O BACK; ADAPTOR, HYGIENE

Model Number	RTL12203KDR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Inflammation (1932)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a bath seat by the end user who reported that one of the bath seat legs broke during use, causing the seat to collapse.As a result, the end user fell and struck her left leg and head on a glass shower door.The end user was diagnosed with tendonitis of the right knee and was prescribed a non-steroidal anti-inflammatory medication.The end user reported experiencing chest pain attributed to the stress of the incident and was subsequently admitted to the hospital for a three-day observation period.The end user's heart function was determined to be normal.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE MEDICAL BATH SEAT W/O BACK
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.96, zhaoyi road; dongsheng town; zhongshan, guangdon 52841 4; CH 528414
• MDR Report Key: 25232094
• Report Number: 2438477-2026-00027
• Device Sequence Number: 16012147
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: (01)00822383246253
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026
• Report Date (Section F): 05/20/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12203KDR
• Device Catalogue Number: RTL12203KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2026
• Event Location: Home
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 05/20/2026