MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. HYALURONATE SODIUM (HYALURONATE NA (EUFLEXXA) 10MG/ML INJ, SYRINGE, 2ML; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Arthralgia (2355); Swelling/ Edema (4577)

Event Date 07/02/2021

Event Type  No Answer Provided  

Event Description

Joint pain and swelling.Suspect drug#1, dosing: injection into knee.Diagnose for use: pain.

• Brand Name: HYALURONATE SODIUM (HYALURONATE NA (EUFLEXXA) 10MG/ML INJ, SYRINGE, 2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 12452637
• MDR Text Key: 271237334
• Report Number: MW5103818
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 87