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

Model Number	RTL12203KDR
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by an end user's wife, who reported that one of the legs of bath bench "collapsed" while in use.There was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive will not be able to perform a product evaluation, as the end user's wife confirmed that she discarded the unit after purchasing a replacement.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: SHOWER 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: 17086938
• Report Number: 2438477-2023-00059
• Device Sequence Number: 2833820
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 06/08/2023
• Report Date (Section F): 06/08/2023

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2023
• Date Report to Manufacturer: 06/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 06/08/2023