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