MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA INJ 10MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Pt noticed that her knee was having more pain while she was walking in (b)(6) in below 0 temperatures.She was curious if there was any info in terms of the medication reacting poorly in colder temperatures.Told pt that there isn't any info that i'm aware of which would indicate one way or another but that arthralgia in general is a potential side effect of the medication.She said she only experienced it in the cold weather.Pt had mentioned it to her provider who wasn't aware if there was any effect either.Dates of use: (b)(6) 2017 - present.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 8191500
• MDR Text Key: 131509461
• Report Number: MW5082510
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): N
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 69 YR