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

Model Number	522-1702-1900
Medical Device Problem Codes	Unintended Movement (3026); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not available for inspection at this time.
Event or Problem Description
The plastic tab on the seat chair popped off causing the seat of this chair to come off and individual to fall on the floor.No injuries were reported.

• Brand Name: DMI ROLLING SHOWER CHAIRWITH 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: 20684986
• Report Number: 1000143485-2024-25328
• Device Sequence Number: 15313698
• Product Code: ILS
• UDI-Device Identifier: 00041298017028
• UDI-Public: 041298017028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/13/2024
• Report Date (Section F): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 522-1702-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/18/2024
• Device Age: 2 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/13/2024