MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE; ROLLATOR

Model Number	R726
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/13/2019
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 retrieved for investigation.End-user was descending from the car reaching out for the rollator when she cut her leg on the brakes.She was taken to the hospital by ambulance where she received stitches.They were unable to reattach all the skin affected.Customer have been told in the hospital that it could take as long as a year to heal.Customer is currently on home health care for this injury.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; 1 chuangye st; sw indust dst; matou eco industry pk, handan city hebei 05604 6; CH 056046
• MDR Report Key: 10396976
• Report Number: 2438477-2020-00037
• Device Sequence Number: 19460097
• Product Code: ITJ
• UDI-Device Identifier: 00822383233215
• UDI-Public: 822383233215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2020
• Report Date (Section F): 08/12/2020

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: Lay User/Patient
• Device Model Number: R726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2020
• Device Age: 26 MO
• Event Location: Other
• Date Report to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2020
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Weight: 125
• Date Report Sent to FDA: 08/12/2020