MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL DRIVE; ROLLATOR

Model Number	R800RD
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive received a report that the end user of a rollator was injured when the rollator "put holes in her legs on 3 occasions due to being sharp." the reporter stated that the end user is on blood thinners and "bled all over the floor," and treated at an urgent care.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 13082961
• Report Number: 2438477-2021-00079
• Device Sequence Number: 5433196
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• Combination Product (Y/N): N
• 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): 12/21/2021
• Report Date (Section F): 12/21/2021

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: R800RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/30/2021
• Device Age: 18 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2021
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 12/21/2021