MAUDE Adverse Event Report: FERRING EUFLEXXA

Lot Number M12039A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Hospitalized for unk reason.Dose or amount: 10mg, frequency: qw, route: sc.Dates of use: (b)(6) 2015 - ongoing.Diagnosis or reason for use: bilateral prim osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING
• MDR Report Key: 6683912
• MDR Text Key: 79069769
• Report Number: MW5070755
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/30/2017
• Device Lot Number: M12039A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR