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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Missed Dose (2561)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Missed dose consult.Euflexxa 20mg pfs last year; 1 dose missed got 2 of 3 injections but, no issues with therapy.Pt continuing next series of injections.No adr reported."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7373266
• MDR Text Key: 103696989
• Report Number: MW5076161
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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: 54 YR