MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 10MG/ML 2ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Pt reported that she had back surgery about 4 weeks ago.This will be arxwps first fill for the pt.Md: (b)(6).

• Brand Name: EUFLEXXA 10MG/ML 2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 12852450
• MDR Text Key: 281165661
• Report Number: MW5105498
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL HFA; ATORVASTATIN ; BUSPIRONE; CEPHALEXIN ; CLOPIDOGREL ; CYCLOBENZAPR ; DICLOFENAC GEL ; DULOXETINE; MIRTAZAPINE; MYRBETRIQ; NORTRIPTYLIN; ORPHENADRINE ER ; TRAZODONE
• Patient Sex: Female