MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; BATH CHAIR

Model Number	RTL12202KDR
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath chair by an end user, who reported that his buttock skin was punctured by a protruding screw in the seat.The end user did not seek any medical treatment as a result of the incident.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 chair by an end user, who reported that his buttock skin was punctured by a protruding screw in the seat.The end user did not seek any medical treatment as a result of the incident.The product was not returned for investigation.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 16763778
• Report Number: 2438477-2022-00140
• Device Sequence Number: 20342051
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023
• Report Date (Section F): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12202KDR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/25/2022
• Event Location: Other
• Date Report to Manufacturer: 04/25/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 11/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 11/08/2023