MAUDE Adverse Event Report: DRIVE; WHEELCHAIR, MANUAL

Model Number	K320DDA-SF
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.We will submit a follow-up report when additional information becomes available.While in use the left side arm pad cut him.The end-user states that there is no wear to the arm pad itself but there's a sharp piece sticking up through the center of the pad about 2 ¿" from the front.No additional information is available.We are filing this report in an overabundance of caution.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR, MANUAL
• MDR Report Key: 12495003
• Report Number: 2438477-2021-00048
• Device Sequence Number: 3695048
• Product Code: IOR
• UDI-Device Identifier: 00822383123370
• UDI-Public: 822383123370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/20/2021
• Report Date (Section F): 09/22/2021

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: Lay User/Patient
• Device Model Number: K320DDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2121
• Device Age: 3 YR
• Date Report to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2021
• 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