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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Movement Disorder (4412)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Euflexxa injection into the right knee.About three hours later, horrible bowel movement knees buckled, had to sit down, very shaky, talking to a friend who suggested i take blood pressure, too shaky to do so.A friend took me to er.I stayed overnight in er.Very disoriented.Could not verbalize my thoughts.Er thought i was having a stroke.I became unconscious.I called the orthopedic office and told them about how i was feeling after the injection.They said to call friday, september 17th if not better, i ended up in er and was not able to call them.Er doctor did.Orthopedic gave the drug by inject.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 12525473
• MDR Text Key: 273389693
• Report Number: MW5104173
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 61