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

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 03/02/2018

Event Type  Injury  

Event Description

Pt reports forming a lot of swelling in her feet and legs after her third shot.The swelling lasted for 3 months.Dates of use: (b)(6) 2018 - (b)(6) 2018.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7979752
• MDR Text Key: 124529740
• Report Number: MW5080681
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• 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: 52 YR