MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; ADAPTOR, HYGIENE

Model Number	12065
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Brain Injury (2219)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a raised toilet seat by the end user's friend who stated that the seat clamps gave out during use causing the end user to fall and injure his head.He was admitted to the hospital for bleeding in the brain.As part of its complaint review and evaluation process, drive devilbiss healthcare will notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; 1 jinshao street; west district; zhongshan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 19533451
• Report Number: 2438477-2024-00031
• Device Sequence Number: 7704317
• Product Code: ILS
• UDI-Device Identifier: 00822383136721
• UDI-Public: 00822383136721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024
• Report Date (Section F): 06/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2024
• Event Location: Home
• Date Report to Manufacturer: 06/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/13/2024