FDA Adverse Event
Death
Summary report: N
EUFLEXXA
MDR report key: 8260547
·
Received January 17, 2019
Report
- Report Number
- MW5083207
- Event Type
- Death
- Date Received
- January 17, 2019
- Report Date
- January 16, 2019
- Manufacturer
- FERRING PHARMACEUTICALS INC.
- 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'S MED OFFICE REPORTED PT DIED BETWEEN (B)(6) 2019. ARXWP NEVER FILLED EUFLEXXA FOR THE PT. STRENGTH: 10 MG/ML - MILLIGRAMS PER MILLILITRES. DOSE OR AMOUNT: 2 ML MILLILITRE(S); FREQUENCY: WEEKLY FOR 3 WEEKS. ROUTE: INTRA-ARTICULAR. DIAGNOSIS OR REASON FOR USE: UNILATERAL PRIMARY OSTEOARTHRITIS, RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52292 | EUFLEXXA | ACID, HYALURONIC, INTRAARTICULAR | MOZ | FERRING PHARMACEUTICALS INC. | 55566410001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |