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

Patient Problems Pain (1994); Tachycardia (2095); Malaise (2359); Neck Pain (2433)

Event Date 07/15/2023

Event Type  Injury  

Event Description

Gotna shot of euflexxa in my knee.Felt ok at first then felt like i had the flu, and heart was beating too fast.Knee paint persists.Neck now hurts too.Knee pain.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC./ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 17374784
• MDR Text Key: 319691649
• Report Number: MW5119835
• 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: Other
• Type of Report: Initial
• Report Date: 07/18/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2023
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White