MAUDE Adverse Event Report: EUFLEXXA INJ 10MG/ML

Device Problem Defective Device (2588)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 07/11/2018

Event Type  Injury  

Event Description

Pt was admitted to hospital due to infection, euflexxa stopped due to not retrieving the desired effect.Dates of use: (b)(6) 2018 to (b)(6) 2018."is the product compounded: no; is the product over-the-counter: no.".

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: EUFLEXXA INJ 10MG/ML
• MDR Report Key: 7734871
• MDR Text Key: 115721817
• Report Number: MW5078710
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 47 YR