MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISREAL) LTD EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Lot Number T16527C

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Inject 1 syringe intra-articularly into the right affected knee weekly for 3 weeks.Inject 1 syringe intra-articularly into the right affected knee weekly for 3 weeks.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISREAL) LTD
• MDR Report Key: 16573649
• MDR Text Key: 311676311
• Report Number: MW5115819
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/23/2023
• Device Lot Number: T16527C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female