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

Model Number	522-1702-1900
Medical Device Problem Codes	Material Separation (1562); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When the hospice caregiver put patient on the shower chair, a clip pulled away from the seat requiring caregivers to hold/support patient "in order" to keeping him from falling to the ground.No injuries were reported.
Additional Manufacturer Narrative
Device was not available for inspection at this time.An email was sent requesting additional information.

• 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: 22044566
• Report Number: 1000143485-2025-26929
• Device Sequence Number: 21052772
• Product Code: ILS
• UDI-Device Identifier: 00041298017028
• UDI-Public: 041298017028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2025
• Report Date (Section F): 05/19/2025

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: Health Professional
• Device Model Number: 522-1702-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2025
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 05/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 53 KG
• Date Report Sent to FDA: 05/19/2025