MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 10 MG/ML 2 ML (6=3SYR); ACID, HYALURONIC, INTRAARTICULAR

Lot Number T10886A

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

Patient Problem Cancer (3262)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Pt's wife (b)(6) reports pt was diagnosed with prostate cancer (b)(6) 2022.Inject 1 syringe intra-articularly to right knee every week for 3 weeks.

• Brand Name: EUFLEXXA 10 MG/ML 2 ML (6=3SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 14593615
• MDR Text Key: 293372708
• Report Number: MW5110090
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 5556641001
• UDI-Public: 5556641001
• 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: 06/01/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: T10886A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: FLOMAX CAP 0.4 MG; LABETALOL TAB 200 MG; METFORMIN TAB 500 MG; MIRTAZAPINE TAB 15 MG; PREDNISONE TAB 5 MG
• Patient Age: 76 YR
• Patient Sex: Male