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

Lot Number N15006A

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

Patient Problems Arthritis (1723); Death (1802)

Event Date 06/22/2018

Event Type  Death  

Event Description

Pt was reported as deceased as of (b)(6) 2018.Bilateral primary osteoarthritis of knee.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 9238861
• MDR Text Key: 163908300
• Report Number: MW5090646
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

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 Operator: No Information
• Device Expiration Date: 06/03/2019
• Device Lot Number: N15006A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 92 YR