BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERRUCA-FREEZE

    MDR report key: 20989771 · Received December 20, 2024

    Report

    Report Number
    1000140327-2024-00001
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    May 19, 2023
    Report Date
    November 19, 2024
    Manufacturer
    CRYOSURGERY, INC.
    Product Code
    GEH
    PMA / PMN Number
    K982506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADVERSE EVENT OCCURRED 1.5 YEARS AGO ON MAY 19, 2023, HOWEVER CRYOSURGERY WAS FIRST NOTIFIED ABOUT THE EVENT ON NOVEMBER 1, 2024 BY ATTORNEYS REPRESENTING THE PATIENT IN A MALPRACTICE LAWSUIT AGAINST THE PROVIDER. THE PATIENT'S ATTORNEYS PROVIDED THOROUGH DOCUMENTATION, INCLUDING VIDEOS OF THE PROCEDURE, PHOTOS OF THE INJURY, AND A FULL INCIDENT REPORT WITH NOTES FROM EACH MEDICAL VISIT. THIS DOCUMENTATION WAS SUFFICIENT IN CONDUCTING A THOROUGH INVESTIGATION AND CONFIRMING THAT THE DEVICE WAS IN GOOD WORKING ORDER AT THE TIME OF THE PROCEDURE. EVALUATION OF THE DEVICE WAS DEEMED UNNECESSARY DUE TO CLEAR INDICATION OF NEGLIGENT USE BY THE PROVIDER. ALL OF THE INFORMATION THAT WE HAVE IS INCLUDED IN THIS REPORT AND OBTAINING FURTHER INFORMATION WOULD BE UNLIKELY DUE TO ONGOING LITIGATION. THIS REPORT WAS INITIALLY COMPLETED ON NOVEMBER 19, 2024; HOWEVER, MDR SUBMISSION IS LATE DUE TO DELAYS ARISING FROM INITIAL SETUP OF ESG & WEBTRADER ACCOUNTS. WEBTRADER TEST SUBMISSIONS SENT NOVEMBER 20, 2024 BUT REVIEW/APPROVAL FOR MIGRATION TO WEBTRADER PRODUCTION ENVIRONMENT NOT FINALIZED UNTIL AFTER THE 30-DAYS-FROM-NOTICE DEADLINE.

    Description of Event or Problem · 0

    PATIENT WAS TREATED FOR REMOVAL OF WART ON LEFT HAND. TREATMENT PROVIDER FAILED TO FOLLOW MANUFACTURER INSTRUCTIONS FOR USE AND MADE SEVERE DEVIATIONS FROM THE PROCEDURE THAT RESULTED IN PROLONGED APPLICATION OF CRYOGENIC AGENT TO THE PATIENT'S SKIN. BY THE FOLLOWING DAY, A LARGE BLISTER HAD FORMED AROUND THE AREA TREATED AND THERE WAS MODERATE SWELLING OF THE LEFT HAND, SO THE PATIENT WENT TO THE ER, WHERE THEY WERE DIAGNOSED WITH SECOND DEGREE BURNS. THE PATIENT HAS SINCE RECEIVED CARE FROM BURN SPECIALISTS AND THE AFFECTED AREA HAS HEALED, HOWEVER IT IS LIKELY THE PATIENT WILL EXHIBIT SOME DEGREE OF PERMANENT PIGMENT LOSS (HYPOPIGMENTATION) AS A RESULT OF THE BURN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151560 VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM GEH CRYOSURGERY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Other