BEUDAMED
    FDA Adverse Event Summary report: N

    DR. SCHOLL'S SKIN TAG REMOVER

    MDR report key: 3199546 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00008
    Date Received
    June 21, 2013
    Report Date
    August 23, 2010
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EYE STINGING [EYES STINGING]. BLURRY EYE [BLURRING OF EYES]. CASE DESCRIPTION: COMPANY NARRATIVE: A SPONTANEOUS REPORT FROM A MALE CONSUMER REGARDING HIMSELF. (AGE NOT PROVIDED). THE CONSUMER MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE CONSUMER INITIATED DR SCHOLL'S SKIN TAG REMOVED FOR SKIN TAGS. DATES AND DOSAGE/FREQUENCY NOT PROVIDED. CONSUMER STATED HE WENT TO USE THE PRODUCT AND PUT IT INTO THE ACTIVATOR AND PUSHED DOWN AND THE CAN KIND OF EXPLODED, LIKE A ROCKET AND SHOT INTO HIS FACE. HE GOT SOME IN HIS EYE; IT'S STOPPED STINGING BUT HIS LEFT EYE IS VERY BLURRY. DECHALLENGE/RECHALLENGE INFORMATION NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. UPDATE ON ((B)(4) 2010): LOT NUMBER AND EXPIRY DATE WERE PROVIDED. THE CONSUMER MENTIONED THAT HE NORMALLY HAS 20/40 VISION, AND HIS EYE IS STILL NOT BACK TO NORMAL. IT'S STILL BLURRY/CLOUDY AND IT TEARS UP WHENEVER A BREEZE HITS IT. HE'S GONE TO SEE A DOCTOR BUT IS WAITING TO FOLLOW UP WITH HIS PHYSICIAN. HE APPARENTLY FLUSHED IT OUT RIGHT AWAY WHEN IT HAPPENED, HE'LL KEEP US POSTED. UPDATE ON ((B)(4) 2010): THE INVESTIGATION REPORT HAS BEEN RECEIVED AND EVALUATED BY MERCK (B)(4) FOR THE REPORTED DEFECTIVE PRODUCT ASSOCIATED WITH AN ADVERSE EVENT. THE INVESTIGATION REPORT HAS ADDRESSED THE REPORTED COMPLAINT AND IS DEEMED SATISFACTORY. BASED ON THE INVESTIGATION REPORT, A POSSIBLE ROOT CAUSE HAS BEEN IDENTIFIED. AS PER THE CONCLUSION OF THE INVESTIGATION PERFORMED BY KIK (B)(4), THERE IS NO NEED TO ISSUE A CAPA FOR A DEFECTIVE PRODUCT OR THE AE SINCE THE POSSIBLE ROOT CAUSE IS MISUSE OF THE PRODUCT. THERE IS NO EVIDENCE OF ANY CONDITION EXISTING DURING MANUFACTURING THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. IT APPEARS THAT THE CONSUMER DID NOT FOLLOW PACKAGING INSTRUCTIONS AND HEED CLEAR PACKAGING WARNING SECTION. FRONT PANEL OF CONTAINER PACKAGING STATES: "CAUTION CONTAINER MAY EXPLODE IF HEATED". IT IS LIKELY THAT THE PACKAGE WAS STORED IN A HEATED LOCATION. NO KIK SUPPLIED PORTION OF THIS PRODUCT COULD BE CONSIDERED AN IGNITION OR HEAT SOURCE. CONCLUSION: AS PER THE CONCLUSION OF THE INVESTIGATION REPORT PERFORMED BY KIK FOR DEFECTIVE PRODUCT AND ASSOCIATED AE, THE COMPLAINT COULD NOT BE VERIFIED SINCE THE COMPLAINT SAMPLE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283747 DR. SCHOLL'S SKIN TAG REMOVER NONE GEH

    Patients

    Seq Age Sex Outcome Treatment
    1