FDA Adverse Event Death Summary report: N

EUFLEXXA

MDR report key: 6621394 · Received June 6, 2017

Report

Report Number
MW5070224
Event Type
Death
Date Received
June 6, 2017
Report Date
June 5, 2017
Manufacturer
FERRING PHARMACEUTICALS
Product Code
MOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PATIENT'S WIFE REPORTED PATIENT IS DECEASED. THE DATE OF DEATH WAS NOT PROVIDED. DOSE OR AMOUNT: 10MG/ML. FREQUENCY: WEEKLY FOR 3 WEEKS. ROUTE: UNDER THE SKIN. DATES OF USE: (B)(6) 2015 - ONGOING. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: DOESN'T APPLY. EVENT REAPPEARED AFTER REINTRODUCTION: DOESN'T APPLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
397875 EUFLEXXA ACID, HYALURONIC INTRAARTICULAR MOZ FERRING PHARMACEUTICALS M14132A

Patients

Seq Age Sex Outcome Treatment
1 66 YR Death