MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; BATH SAFETY BENCH

Model Number	RTL12004KD
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user, who stated that she "leaned back to reach for something that was behind me and the leg gave way, completely bent.I fell back landing on my coccyx first, then the rest of my back and then my head hit the cabinet." the end user reported icing the affected area, taking ibuprofen for pain and seeing a chiropractor.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user, who stated that she "leaned back to reach for something that was behind me and the leg gave way, completely bent.I fell back landing on my coccyx first, then the rest of my back and then my head hit the cabinet." the end user reported icing the affected area, taking ibuprofen for pain and seeing a chiropractor.The product was returned and evaluated.The root cause could not be determined as the end user weight was never provided to confirm if they were within weight capacity (300lbs) utilizing the shower stool.The defect rate for this specific issue is only (b)(4) in 2022 and only one complaint related for 2021.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY BENCH
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15698944
• Report Number: 2438477-2022-00102
• Device Sequence Number: 15012334
• Product Code: ILS
• UDI-Device Identifier: 00822383246581
• UDI-Public: 822383246581
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 11/30/2022
• Report Date (Section F): 11/30/2022

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: RTL12004KD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2022
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 12/07/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/30/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/30/2022