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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 75