MAUDE Adverse Event Report: XIAMEN CARYWELL TECHNOLOGY CO., LTD. DMI; HEAVY DUTY SLIDING TRANSFER

Model Number	522-1734-1900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempted to contact the customer and got no response.Device was not available for inspection.
Event or Problem Description
I bought the item from amazon but it's now broken in less than 2 months.My mom fell and hurt her knee.

• Brand Name: DMI
• Common Device Name: HEAVY DUTY SLIDING TRANSFER
• Manufacturer (Section D): XIAMEN CARYWELL TECHNOLOGY CO., LTD.; no. 39 xinchang road; haicang district; xiamen fujian province ; CH
• MDR Report Key: 19563004
• Report Number: 1000143485-2024-24057
• Device Sequence Number: 12637716
• Product Code: ILS
• UDI-Device Identifier: 00041298003373
• UDI-Public: 041298003373
• Combination Product (Y/N): N
• 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): 06/18/2024

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: 522-1734-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2024
• Device Age: 2 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female