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

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 08/14/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 i had received euflexxa injections in both knees.By the 2nd week, 2nd injection i had pain in my calves, almost a feeling of a pulled muscle.Told nurse at 2nd appointment.3rd injection, i had a lot more pain in my calves, told nurse, she told me she would discuss with doctor, never heard anything more.I left and by week 4, i was hurting very bad.I had some bruising showing on back of left calf.By week 5, bruising went from back of calf, below knee all the way to ankle and top of foot.I called and spoke with nurse.She discussed with doctor and told me it doesn't sound like anything from injections and i should contact primary care doctor, be checked for blood clots.I did and blood work came back normal and my doctor told me i needed to get back in touch with specialist.I called multiple times, left messages.3rd time i was told to come back in.This appointment was on (b)(6) 2023.Prior to this, i contacted manufacturer and fda.Extra blood work to rule out blood clots.I don't have any lab results.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18291279
• MDR Text Key: 330221167
• Report Number: MW5149022
• 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: 12/02/2023

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: 12/07/2023
• Patient Sequence Number: 1
• Treatment: AJOVY.; FISH OIL.; IBUPROFEN.; MAGNESIUM.; POTASSIUM; SUMATRIPTAN (AS NEEDED).
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White