MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVE; BED RAILS

Model Number	15001ABV
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Multiple Fractures (4519)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a bed rail by an end user's husband, who stated that she has "fallen out of her bed due to the right-side rail not being up." the reporter stated that knobs and pins of the rail were "jammed" or broken off.The reporter did not specify how the rail came to be in that condition.The end user went to the hospital and was diagnosed with 3 cracked ribs.Drive is currently investigating the incident, including attempting to inspect the product, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED RAILS
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st.; heping dis.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 17613375
• Report Number: 2438477-2023-00110
• Device Sequence Number: 7510938
• Product Code: FNL
• UDI-Device Identifier: 00822383179490
• UDI-Public: 822383179490
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15001ABV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2023
• Date Report to Manufacturer: 08/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 08/24/2023