BEUDAMED
    FDA Adverse Event Summary report: N

    DR. SCHOLL'S SKIN TAG REMOVER

    MDR report key: 3199535 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00010
    Date Received
    June 21, 2013
    Report Date
    August 9, 2011
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE (NOVEMBER 09, 2011): LOT NUMBER AND EXPIRY DATE PROVIDED. EVAL SUMMARY: PQC SUMMARY: PQC RESULTS: IT WAS REFERRED TO THE MFG SITE KIK BASED ON THEIR EXPERIENCE AND THE INVESTIGATIONS PERFORMED IN THE PAST FOR THIS PRODUCT, THIS COMPLAINT IS NOT RELATED TO PRODUCT QUALITY BUT IS MORE AN ADVERSE STORAGE OR A CONSUMER MISUSE. DO NOT USE THE CAN NEAR A HOT SOURCE. THEREFORE, THIS COMPLAINT DOES NOT REQUIRE FURTHER INVESTIGATION FROM QUALITY ASSURANCE. THE CASE WAS FORWARDED TO THE PRODUCT MANAGER FOR INFO AND TRENDING PURPOSE ONLY. AE OF THIS NATURE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS WILL BE TAKEN IF REQUIRED. NOTE: THE LOT NUMBER REPORTED IS NOT A VALID LOT NUMBER AND THE COMPLAINT SAMPLE WAS NOT RETURNED. CONCLUSION: NO PQC INVESTIGATION IS REQUIRED AS THIS COMPLAINT IS MOST PROBABLY A CONSUMER MISUSE (ADVERSE USAGE). COMPLAINT IS NOT VERIFIED.

    Description of Event or Problem · 1

    BURNT HAIR ON ARM [BURN LOCAL]. CASE DESCRIPTION: COMPANY NARRATIVE: A SPONTANEOUS REPORT FROM A FEMALE CONSUMER WHO IS ALSO A NURSE (AGE NOT PROVIDED). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE CONSUMER INITIATED DR SCHOLL'S SKIN TAG REMOVER ON (B)(6) 2011 (INDICATION, DOSE AND REGIMEN NOT PROVIDED). THE CONSUMER STATED SHE APPLIED THE PRODUCT AND THE CAN LIT ON FIRE. IT BURNT THE HAIR ON HER ARMS AND THE PLASTIC BASE BURNT HER DRESSER. THE SKIN WAS OK BUT THE HAIR ON IT WAS BURNT. THE HAIR WAS GROWING. SHE DIDN'T NEED MEDICAL F/U BECAUSE SHE IS A NURSE. OUTCOME: RECOVERING. DECHALLENGE / RECHALLENGE INFO NOT PROVIDED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282608 DR. SCHOLL'S SKIN TAG REMOVER NONE GEH

    Patients

    Seq Age Sex Outcome Treatment
    1