MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; COMMODE

Model Number	11148-1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a commode by the end user's husband, who reported that "the leg broke while she got up and sprained her wrist," "hurt her left leg," and "also landed on her head." drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a commode by the end user's husband, who reported that "the leg broke while she got up and sprained her wrist," "hurt her left leg," and "also landed on her head." the unit was returned for evaluation, however, not all the components were returned.A complete assembly could not be completed to replicate the issue to determine the root cause.Drive is attempting to procure the missing components to complete an evaluation.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a commode by the end user's husband, who reported that "the leg broke while she got up and sprained her wrist," "hurt her left leg," and "also landed on her head." the unit was returned for evaluation, however, not all the components were returned.A complete assembly could not be completed to replicate the issue to determine the root cause.Drive will continue to monitor complaints for trends.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15484953
• Report Number: 2438477-2022-00093
• Device Sequence Number: 5415423
• Product Code: ILS
• UDI-Device Identifier: 00822383102214
• UDI-Public: 00822383102214
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2023
• Report Date (Section F): 09/26/2022

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: 11148-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 09/30/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/27/2022; 05/25/2023
• 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: Other
• Patient Sex: Female
• Patient Weight: 145 KG
• Date Report Sent to FDA: 09/26/2022