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

Model Number 11148-1

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event 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 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 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
• Type of Device: 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
• MDR Text Key: 300575531
• Report Number: 2438477-2022-00093
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383102214
• UDI-Public: 00822383102214
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022,05/25/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 11148-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Distributor Facility Aware Date: 08/30/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 09/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/27/2022; 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 145 KG