MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO.,LTD MERITS; VISION SPORT

Model Number	P326A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was at her neighbor's house and as she left her driveway that had slight incline the seat post of the chair sheared off causing her to fall out of the chair with the seat on top of her causing injury.She did not want to go to the hospital due to covid.No ambulance was called, her neighbor just brought her into the house.She have a dr's appointment 3/4 8:00 am.
Event or Problem Description
Patient was at her neighbor's house and as she left her driveway that had slight incline the seat post of the chair sheared off causing her to fall out of the chair with the seat on top of her causing injury.She did not want to go to the hospital due to covid.No ambulance was called, her neighbor just brought her into the house.She have a dr's appointment (b)(6) 8:00 am.
Additional Manufacturer Narrative
There was a typing error in the model name of the device in the original submission file (b)(4).The model number for the device is p326a.

• Brand Name: MERITS
• Common Device Name: VISION SPORT
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO.,LTD; no. 18. jingke rd,tpmt park,; nantun district; taichung city, 40852 ; CH 40852
• MDR Report Key: 11637771
• Report Number: 9680333-2021-00002
• Device Sequence Number: 3460768
• Product Code: ITI
• UDI-Device Identifier: 04714379292541
• UDI-Public: 04714379292541
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K012802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: P326A
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR