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

Model Number	04714379292305P325U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Tissue Injury (4559)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VISION ULTRA
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO.,LTD; taichung city, taiwan ; CH
• MDR Report Key: 11636812
• Report Number: 9680333-2021-00001
• Device Sequence Number: 3049207
• Product Code: ITI
• UDI-Device Identifier: 04714379292305
• UDI-Public: 04714379292305
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 04714379292305P325U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2021
• 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: 33 YR
• Patient Weight: 129