MAUDE Adverse Event Report: DRIVE; WHEELCHAIR MANUAL

Model Number	BLS18FBD-ELR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.A follow-up submission will be filed when additional information is available.While in use traveling up a hill the side frame of the device broke.The occupant he fell out of the chair and rolled down the sidewalk, scrapping his arms, legs, and hands and bruising his hip.They took him to the emergency room right after the incident.He had been attending therapy to relearn to walk.This incident set him back from moving forward with learning to walk.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR MANUAL
• MDR Report Key: 12667005
• Report Number: 2438477-2021-00055
• Device Sequence Number: 17218059
• Product Code: IOR
• UDI-Device Identifier: 00822383241142
• UDI-Public: 822383241142
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021
• Report Date (Section F): 10/20/2021

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
• Operator of Device: Other
• Device Model Number: BLS18FBD-ELR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2021
• Device Age: 8 MO
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 10/20/2021