FDA Adverse Event
Death
Summary report: N
EUFLEXXA
MDR report key: 6964334
·
Received October 20, 2017
Report
- Report Number
- MW5072843
- Event Type
- Death
- Date Received
- October 20, 2017
- Date of Event
- July 22, 2017
- Report Date
- October 17, 2017
- Manufacturer
- FERRING PHARMACEUTICALS INC.
- Product Code
- MOZ
- UDI-DI
- 55566410001
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PATIENT DECEASED AS OF (B)(6) 2017. NO FURTHER INFORMATION. DOSE OR AMOUNT: 20 MG. FREQUENCY: Q3W. ROUTE: IA. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: UNILATERAL PRIMARY OSTEOPOROSIS. IS THE PRODUCT COMPOUNDED?: NO. IS THE PRODUCT OVER-THE-COUNTER?: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743945 | EUFLEXXA | ACID, HYALURONIC, INTRAARTICULAR | MOZ | FERRING PHARMACEUTICALS INC. | M15199A | 55566410001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Death |