MAUDE Adverse Event Report: XIAMEN CARYWELL TECHNOLOGY CO., LTD DMI ROLLING SHOWER CHAIR WITH COMMODE; ROLLING SHOWER CHAIR,

Model Number	522-1702-1900
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not available for inspection at this time.No other information on the user received other than hospitalized.No complaint received from actual user of device.
Event or Problem Description
Distributor of device reported "hospitalization".

• Brand Name: DMI ROLLING SHOWER CHAIR WITH COMMODE
• Common Device Name: ROLLING SHOWER CHAIR,
• Manufacturer (Section D): XIAMEN CARYWELL TECHNOLOGY CO., LTD; no. 39 xinchang road; haicang district; xiamen fujian province ; CH
• MDR Report Key: 21163845
• Report Number: 1000143485-2024-25874
• Device Sequence Number: 21162404
• Product Code: ILS
• UDI-Device Identifier: 00041298017028
• UDI-Public: 041298017028
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/15/2025
• Report Date (Section F): 01/15/2025

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
• Device Model Number: 522-1702-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• 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: Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/15/2025