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

Model Number 12203-4

Device Problem Material Deformation (2976)

Patient Problems Fall (1848); Head Injury (1879); Memory Loss/Impairment (1958); Vertebral Fracture (4520)

Event Type  Death  

Event 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
• Type of Device: SHOWER STOOL
• Manufacturer (Section D): DONGGUAN DINGHAN ALUMINIUM CO., LTD.; 5th industry area; xiegang town; dongguan city, guangdong ; CH
• MDR Report Key: 16249393
• MDR Text Key: 308203482
• Report Number: 2438477-2022-00136
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 50822383225154
• UDI-Public: 50822383225154
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 12203-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2023
• Distributor Facility Aware Date: 12/30/2022
• Device Age: 15 YR
• Event Location: Other
• Date Report to Manufacturer: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male