BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER

    MDR report key: 3190955 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00011
    Event Type
    Other
    Date Received
    June 21, 2013
    Report Date
    June 11, 2013
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM CANADA AS RECEIVED FROM A CONSUMER REFERS TO A MALE PATIENT OF UNKNOWN AGE. IN (B)(6) 2013 THE PATIENT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), LOT # 27381-53 FOR WART REMOVAL. NO OTHER CO-SUSPECTS WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE PATIENT USED THIS PRODUCT IN (B)(6) 2013, (B)(6) 2013 AND JUST RECENTLY AT EACH TIME FOR THE RECOMMENDED NUMBER OF DAYS FOR WART REMOVAL ON HIS FINGER. THE PATIENT STATED THAT AFTER USING IT EACH OF THE SEPARATE TIME PERIOD HE EXPERIENCED VISION LOSS (DISABILITY) AND BLURRY VISION. ALSO EVEN AFTER USING IS 3 SEPARATE PERIODS, IT NEVER REMOVED THE WART ON HIS FINGER. THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) WAS INTERRUPTED. THE OUTCOME OF VISION LOSS WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. THE OUTCOME OF NEVER REMOVED HIS WART IS UNKNOWN. THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) WAS RESTARTED AND VISION LOSS AND BLURRY VISION RECURRED. THE OUTCOME OF NEVER REMOVED HIS WART IS UNKNOWN. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), THE LOT NUMBER WAS REPORTED AS 27381-53 AND THE SERIAL NUMBER IS NOT AVAILABLE. ADDITIONAL INFORMATION IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282571 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER NONE GEH 27381-53

    Patients

    Seq Age Sex Outcome Treatment
    1