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

Model Number P326A

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 03/02/2021

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 247024143
• Report Number: 9680333-2021-00002
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 04714379292541
• UDI-Public: 04714379292541
• Combination Product (y/n): N
• PMA/PMN Number: K012802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: P326A
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR