FDA Adverse Event
Injury
Summary report: N
EUFLEXXA
MDR report key: 5080682
·
Received September 11, 2015
Report
- Report Number
- MW5056173
- Event Type
- Injury
- Date Received
- September 11, 2015
- Date of Event
- March 19, 2015
- Report Date
- September 11, 2015
- Manufacturer
- FERRING
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
SHOT IN KNEE (B)(6) 2015, AND (B)(6) 2015. AFTER SECOND SHOT BROKE OUT IN RASH OVER ENTIRE BODY, WENT TO ER, HAD A SHOT, RASH STILL EXISTS TODAY AND SHE CONTINUES TO BE TREATED BY A DERMATOLOGIST. DOSE OR AMOUNT: INJECTION; FREQUENCY: ONCE A WEEK. NO, EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED. DATES OF USE: (B)(6) 2015 - (B)(6) 2015. DIAGNOSIS OR REASON FOR USE: KNEE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602770 | EUFLEXXA | EUFLEXXA | MOZ | FERRING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |