MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO LTD DMI; TOILET SEAT RISER

Model Number	522-1508-1901
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Injury suffered by the cx when they used the item they suffered fractures and was rush to the hospital when it slipped away while she's using it they sent they sent us an email we sent documentation to them then they asked me for the hospital deals at that time i was like they have not sent me deals on the hospital because i was still going through treatment going for physical therapy so i told them i didn't have a yet but i gave them the name of the hospital gave them everything gave them for the doctor said but i just did not have any deal to send and then i went to the hospital when i got to the emergency they said that i uh suffer the fracture after doing the x].
Additional Manufacturer Narrative
Event was entered into amazon.Com through a customer review.No name was given, and no description of the incident was provided.There is no way to follow up with the complaintant.The device is not available for inspection.

• Brand Name: DMI
• Common Device Name: TOILET SEAT RISER
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO LTD; no 1318 west of tanjialing rd; yuyao city, zhejiang provice 31540 8; CH 315408
• MDR Report Key: 19972976
• Report Number: 1000143485-2024-24582
• Device Sequence Number: 8432629
• Product Code: ILS
• UDI-Device Identifier: 00041298991496
• UDI-Public: 041298991496
• 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): 08/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 522-1508-1901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2024
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female