Adverse Event & Product Complaint Report Please enable JavaScript in your browser to complete this form. – Step 1 of 4Please best categorize yourself. *PatientHealthcare Professional / HCP StaffCaregiver / Friend / Relative / OtherSales RepresentativeDo we have your consent to contact the patient or caregiver if we have additional questions? *YesNoSales Rep Name *FirstLastSales Rep Email *Sales Rep Phone *NextReporter InformationName *FirstLastTitle *—Select Title—M.D.D.O.PharmD.P.A.R.Ph.R.N.Dr.Fonseca Biosciences EmployeeHCP Concierge EmployeeOtherAddress *Address Line 1Address Line 2City— Select state —AlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyomingStateZip CodeEmail *Phone *Product InformationName of Suspect Fonseca Product *—Select Product—XTORO® (finafloxacin otic suspension)PreviousNextPatient Identifier (choose at least one) *Patient InitialsPatient Age or Year of BirthPatient Sex (M/F)Patient Initials *Patient Age or Year of Birth *Patient Sex (M/F) *—Select Sex—MFPreviousNextDo you want to report an adverse event and/or product quality complaint? *Adverse EventProduct ComplaintAdverse EventIndicationDosing/Route/Action Taken with Fonseca ProductDetails of Suspected Adverse Reaction *(Onset, Treatment, Relevant Test Results)Concomitant Medication(s)If the patient is the reporter, may we contact their product prescriber? *—Select Option—YesNoPrescriber Name *FirstLastPrescriber Email *Prescriber Phone *Outcome of the Event—Select Option—RecoveredImprovedOngoingUnknownSeriousness Criteria—Select Option—DeathLife-threateningPersistent Disability / IncapacityCongenital AnomalyHospitalization / Prolonged HospitalizationOther Important Medical EventNot SeriousUnknownOther- Cannot Categorize Rep Patient with Product Complaint What is the issue, including a full description and when it was observed (during preparation, during administration or after use): How many units are involved (if multiple units include the lot/serial# if different lots were used): Who attempted the administration, HCP/Patient/Caregiver/unknown: User experience with the product/delivery system (first time, > 12 mon, 1-3 mon, 4-6 mon, 7-9 mon, 10-12 mon, unknown): Did the administrator follow the instructions of use? If no, clarify: Was the package/carton received sealed, if no provide details: Description *Event Date *PreviousSubmit