MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Septic Shock (2068); Swelling (2091)

Event Date 12/06/2017

Event Type  Injury  

Event Description

Pt was injected with euflexxa on (b)(6) 2017.He saw his pcp the same day who noted the area was swollen and puffy.Five days later at noon, he experienced stomach upset and was unable to eat.In the evening, his blood pressure was 77/50 with a pulse of 178.He was hospitalized for 5 days.He spent 3 days in the icu.He was diagnosed with ecoli and eventually septic shock.Pt is feeling much better post discharge.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 7202993
• MDR Text Key: 97751134
• Report Number: MW5074646
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 122