MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; BED, MANUAL

Model Number	15021BV
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed rail by a patient, who reported that as he used the rail to assist with standing up, the bar bent and he fell to the floor, breaking his hip and sustaining other bruises.Drive devilbiss healthcare is in the process of facilitating the return of the product for inspection and will update this report should any additional information become available.

• Brand Name: DRIVE
• Common Device Name: BED, MANUAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 18870238
• Report Number: 2438477-2024-00012
• Device Sequence Number: 7786573
• Product Code: FNJ
• UDI-Device Identifier: 00822383143361
• UDI-Public: 00822383143361
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/08/2024
• Report Date (Section F): 03/08/2024

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: 15021BV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2024
• Event Location: Other
• Date Report to Manufacturer: 03/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• 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: Unknown
• Patient Weight: 226 KG
• Date Report Sent to FDA: 03/08/2024