MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. SODIUM HYALURONATE (EUFLEXXA) 20 MG/2ML; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Erythema (1840); Rash (2033)

Event Date 04/04/2024

Event Type  Injury  

Event Description

Patient had a visit on (b)(6) 2024 with the sports medicine/orthopedic surgery clinic where she was administered hyaluronic acid visco supplementation injection (eurflexxa) for the diagnosis of osteoarthritis of bilateral knees.During this injection on (b)(6), the clinic utilized gebauer's ethyl chloride mist as a local anesthetic prior to the injection.The patient returned to the clinic on (b)(6) 2024 for the 3rd dose of eurflexxa to complete the series.Prior to the 3rd injection, the patient presented with small pruritic rash and erythema at bilateral injection sites without evidence of drainage or pain.The patient noted continued improvement from previous injections.The 3rd injection was prepared with 2% chlorhexidine and ethyl chloride spray.The patient tolerated the procedure well with no complications.Reference report: mw5154138.

• Brand Name: SODIUM HYALURONATE (EUFLEXXA) 20 MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 19172067
• MDR Text Key: 341133769
• Report Number: MW5154137
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Patient Sequence Number: 1
• Treatment: GEBAUER'S ETHYL CHLORIDE MIST. GEBAUER COMPANY.
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White