FDA Adverse Event Death Summary report: N

EUFLEXXA

MDR report key: 7978621 · Received October 17, 2018

Report

Report Number
MW5080621
Event Type
Death
Date Received
October 17, 2018
Date of Event
September 24, 2018
Report Date
October 16, 2018
Manufacturer
FERRING PHARMACEUTICALS
Product Code
MOZ
UDI-DI
55566410001
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 1

PT IS DECEASED. DOSE OR AMOUNT: 20 MG MILLIGRAM(S); WEEKLY FOR 3 WEEKS, INTRA-ARTICULAR. THERAPY START DATE: (B)(6) 2014; THERAPY END DATE: (B)(6) 2018. REASON FOR USE: UNILATERAL PRIMARY OSTEOARTHRITIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
816799 EUFLEXXA ACID, HYALURONIC INTRAARTICULAR MOZ FERRING PHARMACEUTICALS N16434A 55566410001

Patients

Seq Age Sex Outcome Treatment
1 83 YR Death