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

Lot Number R13626A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient has been in the hospital for the past 2 days.And should be released today.

• Brand Name: EUFLEXXA, 10 MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 11019174
• MDR Text Key: 222082467
• Report Number: MW5098398
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/28/2021
• Device Lot Number: R13626A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization