MAUDE Adverse Event Report: BIOVENTUS SUPARTZ FX

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Erythema (1840)

Event Date 07/14/2016

Event Type  Injury  

Event Description

Pt developed redness of the skin which he described as being like "a bad sunburn" and shortness of breath.Dose or amount: 25mg/2.5 ml, frequency: once a week x 5, route: intra-articular.Dates of use: one week.Osteoarthritis.

• Brand Name: SUPARTZ FX
• Type of Device: SUPARTZ FX
• Manufacturer (Section D): BIOVENTUS
• MDR Report Key: 5829647
• MDR Text Key: 50745859
• Report Number: MW5063687
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130444401
• UDI-Public: 89130-4444-01
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR