MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD. DRIVE; ADAPTOR, HYGIENE

Model Number	12039
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident by the end user's spouse involving a tub rail that reportedly came loose while the end user was using it to get out of the bathtub causing her to fall backwards.Emergency room x-rays revealed a broken rib.Drive devilbiss healthcare will update this report should any additional information become available.

• Brand Name: DRIVE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 19205736
• Report Number: 2438477-2024-00021
• Device Sequence Number: 12780428
• Product Code: ILS
• UDI-Device Identifier: 10822383102716
• UDI-Public: 10822383102716
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024
• Report Date (Section F): 04/29/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/02/2024
• Event Location: Home
• Date Report to Manufacturer: 04/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 04/29/2024