FDA Adverse Event
Injury
Summary report: N
EUFLEXXA INJ 10 MG/ML
MDR report key: 7049314
·
Received November 21, 2017
Report
- Report Number
- MW5073481
- Event Type
- Injury
- Date Received
- November 21, 2017
- Date of Event
- September 25, 2017
- Report Date
- November 16, 2017
- Manufacturer
- FERRING PHARMACEUTICALS, INC.
- Product Code
- MOZ
- UDI-DI
- 55566410001
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
SPOKE TO PT REGARDING SIDE EFFECTS SHE HAS BEEN EXPERIENCING DURING THE COURSE OF HER MOST RECENT SERIES OF EUFLEXXA INJECTIONS. SHE STARTED TO EXPERIENCE NOTICEABLY MORE SWELLING AND PAIN IN BOTH HER KNEES BETWEEN THAT FIRST AND SECOND WEEK OF INJECTIONS, AND EVEN MORE SWELLING BETWEEN THE SECOND AND THIRD WEEK OF INJECTIONS. SHE ADVISED THE MDO OF HER ISSUES AND CONCERNS, UPON WHICH THEY TOLD HER "GIVE IT SOME TIME FOR THE INJECTIONS TO TAKE AFFECT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829608 | EUFLEXXA INJ 10 MG/ML | EUFLEXXA INJ 10 MG/ML | MOZ | FERRING PHARMACEUTICALS, INC. | 55566410001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |