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

Model Number	RTL12203KDR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a bath bench by an end user's wife, who stated that "the legs bent out," and reported that her husband fell onto his back.The end user's wife called 911 and emts came to lift him from the bathroom floor, but he did not seek any further medical treatment.The end user has been taking tylenol for pain since 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.
Additional Manufacturer Narrative
The defective device was returned to drive devilbiss and it was confirmed that the legs were bent on the frame.The device was then sent to the supplier manufacturer for further investigation.The supplier tested the defective unit with a replacement leg (to replace the bent leg) and it passed testing and was found to be compliant.The supplier then performed a failure/destructive test where they shook the unit during testing to mimic user misuse.The unit failed with the shaking.Therefore, the supplier determined the unit failed likely due to misuse.

• 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: 17377408
• Report Number: 2438477-2023-00097
• Device Sequence Number: 17801856
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/24/2023
• Report Date (Section F): 03/26/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 07/24/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 03/26/2024
• 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: Other
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 205 KG
• Date Report Sent to FDA: 03/26/2024