MAUDE Adverse Event Report: COMBO (ZHING SHAN) MEEDICAL DRIVE; ROLLATOR

Model Number	10257RD-1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device whichi ia a rollator.The unit was taken and cannot be retrieved for evaluation.Caretaker used the rollator as a transport chair.End-user's leg was cut by the brake while being push through a doorway.Owner's manual/ ifu specifically states: "important safety notice: do not have anyone push you while you are seated on the rollator.This is a walking aid only and is not to be used as a transportation device.".

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COMBO (ZHING SHAN) MEEDICAL; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 10740778
• Report Number: 2438477-2020-00053
• Device Sequence Number: 17021696
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/26/2020
• Report Date (Section F): 10/26/2020

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: 10257RD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2020
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2020
• 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
• Date Report Sent to FDA: 10/26/2020