MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	10233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will submit a follow-up when additional information becomes available.The end-user rolled out of bed and landed on her rollator.She was impaled on the wheellock of her rollator.The device was stuck in her leg for approximately an hour until it was removed.No further information has been provided at this time.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12881966
• Report Number: 2438477-2021-00073
• Device Sequence Number: 11968925
• Product Code: ITJ
• UDI-Device Identifier: 00822383118550
• UDI-Public: 822383118550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/29/2021
• Report Date (Section F): 11/29/2021

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: 10233
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2021
• 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: Female
• Date Report Sent to FDA: 11/29/2021