MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10 MG/ML 2ML (6=3SYR); ACID, HYALURONIC, INTRAARTICULAR

Lot Number T10187A

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

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  Death  

Event Description

Event: pt's daughter reported pt passed away (b)(6) 2021.Inject 1 syringe intra-articularly into the left knee once a week for 3 weeks.

• Brand Name: EUFLEXXA 10 MG/ML 2ML (6=3SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 13059205
• MDR Text Key: 282615163
• Report Number: MW5106171
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: T10187A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Sex: Female