CardioMed Customer Problem Report 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.AmyBillBruceChristineElieJamalMichelRaphaelToddSomeone ElseIssue 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.
