MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC./BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144)

Event Date 02/13/2019

Event Type  Injury  

Event Description

After 1 injection of euflexxa (1st of 3), headache first day, intractable vomiting began approx.22 hrs later.Unable to keep food or fluids down for 60 hrs, nausea lasted 6 days total and stomach is still sensitive today.Additionally, my knee locked up in the shower and would not bend.I declined any further injections.I did not have this problem with synvisc.Of note: i have me/cfs and have an overactive immune response.It is possible my body sees the euflexxa as an invader of some type.Why was the person using the product? bone on bone osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC./BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 8363277
• MDR Text Key: 137203285
• Report Number: MW5084268
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 128