MAUDE Adverse Event Report: COMBO (ZHONGSHAN) MEDICAL EQUIPMENT DRIVE MEDICAL; ADAPTOR, HYGIENE

Model Number RTL12036-ADJ

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/29/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a tub rail by the end-user's son, who stated that the tub rail moved while in use, causing him to fall.The fall reportedly resulted in fractured ribs on his right side, and he is being evaluated by an orthopedic doctor.Drive devilbiss healthcare is currently investigating the incident, including requesting the return of the device for evaluation, and an update will be filed if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): COMBO (ZHONGSHAN) MEDICAL EQUIPMENT; no.6 tongxing east road; dongsheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 18287052
• MDR Text Key: 329996089
• Report Number: 2438477-2023-00146
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL12036-ADJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2023
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Home
• Date Report to Manufacturer: 12/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male