MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE; WALKER

Model Number	10226G
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.The unit has not been returned for evaluation.While using the walker in the rest room the leg reportedly snapped around the screw, the end-user fell and hit her head and shoulder.She was c on the dresser.She was taken to the hospital, they x-rayed her femur which was the initial cause for her use of the device.She was released from the er the same day with instructions to take tylenol.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; 98, zhaoyi road,; dongsheng town; zhongshan city,, guangdong, 52841 4; CH 528414
• MDR Report Key: 9183070
• Report Number: 2438477-2019-00068
• Device Sequence Number: 2614973
• Product Code: ITJ
• UDI-Device Identifier: 00822383253336
• UDI-Public: 822383253336
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/11/2019
• Report Date (Section F): 10/11/2019

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: 10226G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2019
• 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: 79 YR
• Patient Weight: 78
• Date Report Sent to FDA: 10/11/2019