MAUDE Adverse Event Report: DRIVE; WHEELCHAIR, MANUAL

Model Number	K318DDA-SF
Health Effect - Clinical Code	Laceration(s) (1946)
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 was not returned for evaluation.We will submit a follow-up if additional data becomes available.The end-user was a resident of hospice care.While sitting in the chair the user's leg was lacerated by the caster bolt.The caregiver and nurse bandaged and redressed the wound.The end-user passes away from the infirmary that caused her to be a hospice resident.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR, MANUAL
• MDR Report Key: 12464512
• Report Number: 2438477-2021-00043
• Device Sequence Number: 3655514
• Product Code: IOR
• UDI-Device Identifier: 00822383123356
• UDI-Public: 822383123356
• Combination Product (Y/N): N
• 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): 09/13/2021

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: K318DDA-SF
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2021
• 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: Required Intervention