Warranty Claim Warranty Claim - Complaint Report Only One Implant or One Other Issue Per Complaint Please This report is from* Patient Physician's Office Healthcare Facility Other Specify Physician or Facility Name Specify Other Reporter Name of Person Completing this Report* First Last Date* MM slash DD slash YYYY Email* Phone*Street Address* Street Address Address Line 2 City State / Province / Region ZIP / Postal Code AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands Country Reporter also sent report to regulatory authority?* No Yes Specify Regulatory Authority Date of Complaint Onset* MM slash DD slash YYYY Complaint Involves*Select OneRight ImplantLeft ImplantOther IssueComplaint Summary*Patient InformationName* First Last Date of Birth* MM slash DD slash YYYY Implant ProcedureDate of Procedure Known?* Date Unknown Date Known Date MM slash DD slash YYYY For:*Select OneAugmentationRevision AugmentationReconstructionRevision ReconstructionUnknownImplanting Surgeon* Not Known Known - Reporting Physician Known - Other Physician Name of Other Physician Implant InformationImplant Complaint*Select OneDeflationCapsular ContractureOtherImplant Size*Select OneNot Known210cc240cc270cc300cc335cc370cc405cc440cc475cc515cc555cc595cc635cc675ccIs Serial Number Known?* No Yes Serial Number 7 DigitsIs Reoperation Planned?* No Yes, reoperation is scheduled Reoperation has been done Approximate Date: MM slash DD slash YYYY Select Scheduled Procedure:Explant (with or without replacement)Capsule procedure (only)Other (specify)Completed Reoperation Date: MM slash DD slash YYYY Select Completed Procedure:Explant (with or without replacement)Capsule procedure onlyOther (specify)Specify Other Reoperation Procedure Explant Information No replacement Replacement with IDEAL IMPLANT Replacement with other manufacturer's implant Explanting Surgeon Not Known Known - Reporting Physician Known - Other Physician (specify) Reoperating Surgeon Not Known Known - Reporting Physician Known - Other Physician (specify) Other Physician Name RequestsRequested Action(s) Send explant kit Issue credit for replacement implant Financial assistance - Will submit signed claim form and receipts. Other Other Requested Action If you need help with this form or need to make changes after submission, please contact Ideal Implant Warranty Department at: 214-492-2500 Δ FR 043 Rev 00 March 24, 2021 DCR 21-004 Ideal Implant Incorporated
