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

Model Number	522-1702-1900
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injuries reported.Unit over 3 years, supplier has since made clips stronger and more durable.
Event or Problem Description
Clips on one side of seat of unit failed, causing the seat to drop and user to fall halfway to the floor before she caught herself on hand rails.No injury to user reported.

• Brand Name: DMI ROLLING SHOWER CHAIR
• 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: 25174577
• Report Number: 1000143485-2026-28987
• Device Sequence Number: 10524039
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026
• Report Date (Section F): 05/14/2026

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: 04/20/2026
• Device Age: 3 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Date Report Sent to FDA: 05/14/2026