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

Model Number RTL12202KDR

Device Problem Unstable (1667)

Patient Problems Head Injury (1879); Laceration(s) (1946)

Event Date 03/14/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bath chair by an end user, who stated that the "legs wobble and are not even," and he "hit his head and received cuts on his leg." 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.

• Brand Name: DRIVE
• Type of Device: 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: 16724400
• MDR Text Key: 313149013
• Report Number: 2438477-2023-00031
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Distributor Facility Aware Date: 03/14/2023
• Device Age: 8 MO
• Date Report to Manufacturer: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 88 KG