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

Lot Number U10060A

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Patient reported a change in diagnosis non-invasive noma removed on back of arm/elbow.Needs another procedure scrap and burn but not for a couple months.Patient reported updates or changes in medications ozempic.Prescriber contact information: (b)(6).

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC./ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 17039291
• MDR Text Key: 316431499
• Report Number: MW5118019
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

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
• Device Lot Number: U10060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Patient Sequence Number: 1
• Treatment: JARDIANCE TAB 25MG, METFORMIN TAB 500MG, OZEMPIC INJ 2MG/3ML.
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female