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

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

Patient Problem Headache (1880)

Event Date 05/31/2017

Event Type  Injury  

Event Description

Pt reported headache after the euflexxa injection.Therapy is completed.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 6614166
• MDR Text Key: 76863459
• Report Number: MW5070178
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 57 YR