BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POINTTS WART REMOVAL SYSTEM - BRAZIL

    MDR report key: 10016855 · Received May 1, 2020

    Report

    Report Number
    3004142665-2020-00002
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    January 6, 2020
    Report Date
    May 1, 2020
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    ORE
    UDI-DI
    00650240030499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSUMER REPORTED THE THE POINTTS WART REMOVER PRODUCT CAUSED A PAINFUL WOUND ON THIER FACE IN WHICH DISCHARGES SECREATIONS. THE CONSUMER STATED THAT THEY USED THE PRODUCT ACCORDING TO THE PRODUCT INSTRUCTIONS BUT NO USAGE DETAILS WERE PROVIDED. THE QUESTIONNAIRE PROVIDED STATED BURNING FROM THE TREATMENT LASTED FOR DAYS AND A PULSATING PAIN WOULD NOT STOP. THE SKIN WAS REPORTED TO HAVE A LARGE RED AND SPOTTED LESION AT THE SITE OF TREATMENT. THE CONSUMER STATED THAT THE WOUND ON THE FACE FROM THE TREATMENT CAN NOW ONLY BE CORRECTED BY A MEDICAL PROFESSIONAL. NO USUAGE DETAILS WERE PROVIDED BY THE CONSUMER SO THE NUMBER OF TREATMENTS, HOW LONG THE PRODUCT WAS CHARGED AND HOW LONG THE PRODUCT WAS APPLIED CAN NOT BE CONFIRMED. NO INFORMATION WAS PROVIDED ON WHETHER THE WART/VERRUCA WAS DIAGNOSED BY A MEDICAL PROFESSIONAL. ACCORDING TO THE PRODUCT INSERT, IF THE CONSUMER IS UNSURE OF WHAT TYPE OF WART THEY ARE TREATING, CONSULT A DOCTOR BEFORE USING THE POINTTS WART REMOVAL SYSTEM. IT IS POSSIBLE THE CONSUMER'S WARTS WERE NOT SUITABLE FOR USE WITH THE POINTTS PRODUCT. DUE TO THE LACK OF INFORMATION REPORTED THIS COMPLAINT WILL BE RESOLVED AS UNCONFIRMED. AN E-MAIL FROM GENOMMA REPORTED THAT NO FURTHER INFORMATION WAS TO BE EXPECTED FROM THE CONSUMER.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THE THE POINTTS WART REMOVAL SYSTEM CAUSED A PAINFUL WOUND WHICH DISCHARGES SECRETIONS. THE CONSUMER STATED THAT THEY USED THE PRODUCT ACCORDING TO THE PACKAGE INSERT DIRECTIONS ALTHOUGH NO DETAILED USAGE DETAILS WERE PROVIDED. THE CONSUMER ALSO STATED THE BURNING FROM THE APPLICATION LASTED FOR DAYS ALONG SIDE PULSATING PAIN WHICH HAD NOT STOPPED. THE SKIN WAS NOTED TO HAVE A LARGE RED AND SPOTTED LESION FROM THE TREATMENT. THE CONSUMER DID STATE THAT HE WOUND WAS ON THEIR FACE WHICH IMPLIES WHERE ON THE BODY THE PRODUCT WAS USED. THE CONSUMER STATED THAT SINCE THE WOUND WAS ON THEIR FACE IT COULD ONLY BE TREATED BY A DOCTOR ALTHOUGH NO MENTION OF MEDICAL TREATMENT WAS SOUGHT FOR THE INJURY. THIS INFORMATION WAS FORWARDED TO ORASURE TECHNOLOGIES INC. ON A QUESTIONNAIRE FROM GENOMMA LABORITORIES INTERNATIONAL.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE POINTS WART REMOVAL SYSTEM CAUSED A PAINFUL WOUND WHICH DISCHARGES SECRETIONS. THE CONSUMER STATED THAT THEY USED THE PRODUCT ACCORDING TO THE PACKAGE INSERT DIRECTIONS ALTHOUGH NO DETAILED USAGE DETAILS WERE PROVIDED. THE CONSUMER ALSO STATED THE BURNING FROM THE APPLICATION LASTED FOR DAYS ALONG SIDE PULSATING PAIN WHICH HAD NOT STOPPED. THE SKIN WAS NOTED TO HAVE A LARGE RED AND SPOTTED LESION FROM THE TREATMENT. THE CONSUMER DID STATE THAT HE WOUND WAS ON THEIR FACE WHICH IMPLIES WHERE ON THE BODY THE PRODUCT WAS USED. THE CONSUMER STATED THAT SINCE THE WOUND WAS ON THEIR FACE IT COULD ONLY BE TREATED BY A DOCTOR ALTHOUGH NO MENTION OF MEDICAL TREATMENT WAS SOUGHT FOR THE INJURY. THIS INFORMATION WAS FORWARDED TO ORASURE TECHNOLOGIES INC. ON A QUESTIONNAIRE FROM GENOMMA LABORITORIES INTERNATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481617 POINTTS WART REMOVAL SYSTEM - BRAZIL POINTTS WART REMOVAL SYSTEM ORE ORASURE TECHNOLOGIES INC. 1001-0280 7093 00650240030499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other