BEUDAMED
    FDA Adverse Event Summary report: N

    DR SCHOLL'S SKIN TAG REMOVER

    MDR report key: 3199534 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00009
    Date Received
    June 21, 2013
    Report Date
    June 27, 2011
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PQC SUMMARY - UPDATE ((B)(4) 2011): (B)(4) COMPLAINTS WERE RECEIVED FOR THIS PRODUCT SINCE 2009. THIS IS THE FIRST COMPLAINT RECEIVED FOR BOTTLE DEFECTIVE AND THE 5TH COMPLAINT REPORTED AS AN AE. SINCE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR RETURN AND THE LOT NUMBER WAS NOT REPORTED AT THE INITIAL COMPLAINT INTAKE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE COMPLAINT WILL BE CLOSED AS IS. KIK HAS BEEN NOTIFIED AND WILL RECORD THIS COMPLAINT FOR TRENDING PURPOSE ONLY. IN THE EVENT THAT THE SAMPLE OR MORE DETAILS WOULD BECOME AVAILABLE, THE INVESTIGATION WILL BE REOPENED. CONCLUSION: THE COMPLAINT COULD NOT BE VERIFIED SINCE THE SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT SINGED ALL MY HAIR (HAIR BURNED) [BURN]; HAVE A MARK ON MY HAND (SKIN DISCOLOURATION) [SKIN DISCOLORATION]. CASE DESCRIPTION, COMPANY NARRATIVE: A SPONTANEOUS REPORT FROM A FEMALE CONSUMER (AGE NOT PROVIDED). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT PROVIDED. THE CONSUMER INITIATED DR SCHOLL'S SKIN TAG REMOVER ON AN UNK DATE. CONSUMER'S DOCTOR RECOMMENDED SHE USE THE PRODUCT. THE CONSUMER STATED THAT THE PRODUCT BLEW UP IN HER FACE. SHE FOLLOWED ALL INSTRUCTIONS; WHEN SHE PRESSED IT DOWN FOR 3 SECONDS AND IT BLEW UP IN FLAMES. IT SINGED ALL HER HAIR BADLY. THE CONSUMER HAD TO TRIM HER HAIR. ALSO, SHE HAS A MARK ON HER HAND. THE OUTCOME IS UNK. DECHALLENGE/RECHALLENGE INFO NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283396 DR SCHOLL'S SKIN TAG REMOVER NONE GEH SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1