MAUDE Adverse Event Report: DONGGUAN DINGHAN ALUMINIUM CO., LTD. DRIVE; SHOWER STOOL

Model Number	12203-4
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Memory Loss/Impairment (1958); Vertebral Fracture (4520)
Type of Reportable Event	Death
Event or Problem Description
(b)(4) was notified of an incident involving a shower chair by a letter from an attorney, stating that "the legs on the chair bent, causing the end user to fall and hit his head," reportedly causing him to have "fractured his spine" and causing "pain in his hips, back, and head." he was kept for observation in the hospital for 4 days.The product was owned by a hotel, where it was lent out to guests such as this end user, and was reportedly over 15 years old.(b)(4) is currently investigating the incident, including scheduling an inspection, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: SHOWER STOOL
• Manufacturer (Section D): DONGGUAN DINGHAN ALUMINIUM CO., LTD.; 5th industry area; xiegang town; dongguan city, guangdong ; CH
• MDR Report Key: 16249393
• Report Number: 2438477-2022-00136
• Device Sequence Number: 6307068
• Product Code: ILS
• UDI-Device Identifier: 50822383225154
• UDI-Public: 50822383225154
• 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): 01/26/2023
• Report Date (Section F): 01/26/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12203-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2022
• Device Age: 15 YR
• Event Location: Other
• Date Report to Manufacturer: 02/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2023
• 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: Death
• Patient Sex: Male
• Date Report Sent to FDA: 01/26/2023