MAUDE Adverse Event Report: FERRING PHARMACEUTIALS INC. EUFLEXXA; ACID, HYALURONIC INTRAARTICULAR EUFLEXXA

Lot Number N17296A

Device Problem Insufficient Information (3190)

Patient Problems Eye Injury (1845); Intraocular Pressure Increased (1937)

Event Date 09/20/2018

Event Type  Injury  

Event Description

Patient states he has increased pressure in his eyes after he got his last shot of euflexxa.Had to schedule surgery to relieve the pressure and it has caused damage to his eyes.Mdo is aware of this.Strength: 10 mg/mi-milligrams per millilitres; dose or amount: 2 ml milliliter(s); frequency: weekly for 3 weeks; route: intra-articular; diagnosis or reason for use: unilateral primary osteoarthritis-right knee.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC INTRAARTICULAR EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTIALS INC.
• MDR Report Key: 8212408
• MDR Text Key: 132201589
• Report Number: MW5082751
• 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: Patient
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/16/2019
• Device Lot Number: N17296A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR