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 |