MAUDE Adverse Event Report: EUFLEXXA ; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Hyperglycemia (1905)

Event Date 08/19/2018

Event Type  Injury  

Event Description

Pt states his glucose level increase while on euflexxa.I checked clinical pharmacology and states that 0.2 percent of pt, euflexxa can raise blood glucose level.Pt states he only has 1 more dose left and he will discuss with his dr.Inj 10mg/ml, frequency: prn, route: intra-articular - for 2 weeks.Udi: (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7813369
• MDR Text Key: 118383014
• Report Number: MW5079387
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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 Age: 54 YR