MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; WALKER

Model Number	10220-1WW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a walker.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.Customers walker was caught in the carpet causing him to fall damaging the walker.He fell and hit his head and sustained a small cut which required a staple.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road,; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 10090304
• Report Number: 2438477-2018-00065
• Device Sequence Number: 19489468
• Product Code: ITJ
• UDI-Device Identifier: 00822383901145
• UDI-Public: 822383901145
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/26/2020
• Report Date (Section F): 05/26/2020

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: Lay User/Patient
• Device Model Number: 10220-1WW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/06/2018
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 05/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2020
• 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 Weight: 159
• Date Report Sent to FDA: 05/26/2020