MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; RAISED TOILET SEAT

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
Per mdr 2438477-2024-00031: 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: RAISED TOILET SEAT
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 19535503
• Report Number: 3014644996-2024-00011
• Device Sequence Number: 17696324
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 12065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male