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

Model Number	RTL12202KDR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a bath chair from an end user, who reported that he while he was in the shower, the "chair tipped back, he fell backwards and hit his head.Banged his head, turned red." he did not seek medical treatment.The end user's daughter reported that "the lack of suction caused the unit to tip over" and confirmed that there is no other defect in the chair.The end user declined to return the unit for evaluation.

• 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: 15379078
• Report Number: 2438477-2022-00059
• Device Sequence Number: 5796888
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/08/2022
• Report Date (Section F): 09/08/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12202KDR
• Device Catalogue Number: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 09/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 09/08/2022