MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYMOVIS INJ 24MG/3ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2020

Event Type  Injury  

Event Description

Off-label dosing prescribed for hymovis, provider prefers to give injection 2 weeks apart vs approved dose of 1 week apart per (b)(6)., ma.

• Brand Name: HYMOVIS INJ 24MG/3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FIDIA FARMACEUTICI SPA
• MDR Report Key: 9915534
• MDR Text Key: 186300550
• Report Number: MW5094009
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89122049663
• UDI-Public: 89122049663
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR