Contact DetailsYour Information The details about you, the reporter of this issue.Your name*Your Job Title*Your Sales Representative*Who do you typically deal when you communicate with CardioMed? If you're not certain please select 'Someone Else' at the bottom.AmyBillBruceChristine D.ElieJamalMichelRaphaelToddSomeone ElseJustinChristine M.Issue Location Information Please be specific as possible regarding the location of the incident.Site Name*Site Department*Site Address*Site Complaint Reference Number (if applicable)Site Contact Person Name*Site Contact Person Job TitleSite Contact Person Phone NumberSite Contact Email*Product InformationProduct Code*Product Lot Number and/or Serial Number*Some products have a serial number with no lot number, or lot number and no serial number, some have both. Please be as specific as possible.Product Description*Type of Procedure the device was used for*Date product was initially used* Date Format: MM slash DD slash YYYY Date product problem occurred* Date Format: MM slash DD slash YYYY Number of involved problematic products*Product Availability and ReturnAre the involved products available to be returned to CardioMed for testing?*Please Select an optionYesNoProduct is available for TestingHow many units are being returned for investigation?*Indicate Decontamination Performed*Please note that a Completed Decontamination Certificate is required before the return of used samples can be authorized.Product NOT available for testingWas the product disposed of?*YesNoProblem Report Please give us as much detail as possible.Describe Product Problem*Does the incident information you are currently recording indicate any of the following:Detected Prior to Use:*Please Select an optionYesNoBlood Loss (Considered Clinically Significant)*Please Select an optionYesNoSerious injury or Death*Please Select an optionYesNoProperty Damage*Please Select an optionYesNoMedical or Surgical intervention required*Outside the normal scope of work such as routine change or maintenancePlease select an optionYesNoCurrent Patient Status* Returned to baseline Prolonged Hospitalization Disability/Impairment Device was replaced with no further problems encountered*Please select an optionYesNoMedical Intervention, Serious Injury or Death More details regarding the incident.Current Patient Status?Method of Medical Intervention RequiredDate of DeathIn-case of fatality, if not leave blank Date Format: MM slash DD slash YYYY Competent Authority Notified?YesNoCompetent Authority Notified byCustomerCardioMed Supplies, Inc.Date Reported Date Format: MM slash DD slash YYYY Time : HH MM AM PM Competent Authority ReferenceComplete, Please click Submit.
