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

Lot Number R15226A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Swelling/ Edema (4577)

Event Date 11/17/2021

Event Type  Injury  

Event Description

Pr is a (b)(6) y.O.Female on service for euflexxa 20 mg ia in each knee for osteoarthritis from (b)(6) 2021.Patient experienced low level swelling on injection around (b)(6) 2021.Patient may change injections if side effects are experienced or intolerable in the future.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 12883919
• MDR Text Key: 281436682
• Report Number: MW5105643
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566-4100-01
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/20/2022
• Device Lot Number: R15226A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White