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

Model Number	10257BL-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an over-abundance of caution due to an mdr regression analysis.Deice was not returned for evaluation as it was a customer use error.End-user was exiting an elevator when his food caught on the rug.He was holding the loop brake as he fell and he brake broke.He hit his head.He was taken to the hospital and received stitches.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT; liaoan village,; wanshi town; fuyang district, hangzhou city zhejiang, 31140 6; CH 311406
• MDR Report Key: 10885151
• Report Number: 2438477-2018-00086
• Device Sequence Number: 19606640
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/13/2020
• Report Date (Section F): 11/23/2020

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: 10257BL-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2018
• Device Age: 24 MO
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2020
• 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: 76 YR
• Patient Weight: 113
• Date Report Sent to FDA: 11/23/2020