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

Model Number 04714379292305P325U

Device Problem Fracture (1260)

Patient Problems Cellulitis (1768); Unspecified Tissue Injury (4559)

Event Date 03/03/2021

Event Type  Injury  

Event Description

The seat post of an end user's power chair has broken off completely while the end user was occupying it and the end user was injured.It was later reported to us (24mar2021) that she had been hospitalized and had to have surgery on her eyelid due to cellulitis.

• Brand Name: MERITS
• Type of Device: VISION ULTRA
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO.,LTD; taichung city, taiwan ; CH
• Manufacturer (Section G): MERITS HEALTH PRODUCTS CO.,LTD; no. 18. jingke rd,tpmt park; nantun district; taichung city 40852
• Manufacturer Contact: efy cheng ; no. 18. jingke rd,tpmt park,; nantun district; taichung city, 40852 ; CH 40852
• MDR Report Key: 11636812
• MDR Text Key: 245925127
• Report Number: 9680333-2021-00001
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 04714379292305
• UDI-Public: 04714379292305
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 04714379292305P325U
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR
• Patient Weight: 129