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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 06/06/2019

Event Type  Injury  

Event Description

Doctor wrote prescription for injecting into alternating knees weekly for a total of 4 weeks.I advised this is atypical, dosing is usually weekly for 2 weeks into bilateral knees (if both knees are to be treated) and dr's office confirmed to continue with atypical dosing.

• Brand Name: HYMOVIS INJ 24MG/3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FIDIA PHARMA USA; florham park NJ
• MDR Report Key: 8696582
• MDR Text Key: 148066100
• Report Number: MW5087338
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 58 YR