MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE; WALKER

Model Number	10226-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a walker.(b)(4) became aware of the incident upon receipt of a lawyer's letter.(b)(4) does not expect to receive the device for evaluation.We have received photos of the broken device.Patient was in the hospital recuperating from knee replacement surgery.The hospital supplied the device to the patient.The walker reportedly broke during use causing the patient to fall and break his knee cap.We are awaiting additional data and supporting documentation.We will file a follow-up submission if and when this occurs.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; 98, zhaoyi road,; dongsheng town; zhongshan city, 52841 4; CH 528414
• MDR Report Key: 8918804
• Report Number: 2438477-2019-00054
• Device Sequence Number: 16601544
• Product Code: ITJ
• UDI-Device Identifier: 00822383121680
• UDI-Public: 822383121680
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/21/2019
• Report Date (Section F): 08/21/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10226-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/09/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2019
• 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: Required Intervention
• Date Report Sent to FDA: 08/21/2019