MAUDE Adverse Event Report: EUFLEXXA; ACID, HYALURONIC

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

Patient Problems Dyspnea (1816); Anaphylactoid (2218); Reaction (2414)

Event Date 11/25/2015

Event Type  Other  

Event Description

Anaphylactic reaction to euflexxa injection.Approx 20 minutes after the injection, difficulty swallowing, breathing, throat tightening.Reason for use: torn meniscus.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC
• MDR Report Key: 5646259
• MDR Text Key: 44906554
• Report Number: MW5062183
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 73