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

Lot Number N10839C

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Unspecified Infection (1930); Inflammation (1932)

Event Date 06/29/2018

Event Type  Injury  

Event Description

Pt reported she was hospitalized and treated for pericarditis.Unilateral primary osteoarthritis, left knee; 10 mg/ml - milligrams per millilitres, dose or amount: 2 ml millilitre(s), frequency: weekly for 3 weeks, route: intra-articular, therapy start date: (b)(6) 2016.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 7681309
• MDR Text Key: 113883347
• Report Number: MW5078345
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566-4100-01
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/04/2018
• Device Lot Number: N10839C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR