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 |