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

Model Number 12036

Device Problem Material Integrity Problem (2978)

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

Event Date 07/22/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bathtub safety rail by an end user, who reported that he generally uses the bathtub rail to assist in getting up from the toilet, because his bathtub is very close to his toilet.During the incident, when he grabbed the bathtub rail to get up from the toilet, it fell off the tub and he fell, hitting his head and cutting his fingers on the rail.The end user did not provide any information regarding what angle he repeatedly grabbed the bathtub rail to assist in getting off the toilet, or how the bathtub rail was installed at the time of the incident.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.

• Brand Name: DRIVE
• Type of Device: SAFETY RAIL
• 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: 15373055
• MDR Text Key: 299449089
• Report Number: 2438477-2022-00084
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 10822383102679
• UDI-Public: 10822383102679
• 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: 09/07/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Event Location: Home
• Date Report to Manufacturer: 09/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 82 KG