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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Cramp(s) (2193)

Event Date 05/31/2018

Event Type  Injury  

Event Description

Severe cramp in the calf after my second injection, painful to where i was crying and my two boys had to rub the cramp out of my calf. Lasted for 3-4 mins, very painful. Told physician, he stated the injection has nothing to do with the cramping. I disagree, i've never had a calf cramping before. Date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018. Reason for use: osteoarthritis; 3 injection(s), frequency: once wk for 3 wks, topical.

• Brand Name: EUFLEXXA
• Type of Device: ACID HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 7586500
• MDR Text Key: 110734300
• Report Number: MW5077725
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 06/08/2018 Patient Sequence Number: 1