BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR

    MDR report key: 3190441 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00004
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    January 2, 2008
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. CONSUMER UPDATE RECEIVED (B)(6) 2008. NO ADDITIONAL DEMOGRAPHIC INFORMATION WAS PROVIDED. CONSUMER STATED, "I AM ENCLOSING A RECEIPT FOR CHARGES TO REMOVE THE SKIN TAG [ADDITIONAL INDICATION]. ON THE THIRD TREATMENT, THE CAN JUST KINDA EXPLODED AND LEAKED ALL OF THE SOLUTION OUT [ADDITIONAL ADVERSE EVENT]." A QUALITY INVESTIGATION WAS PERFORMED AND THE RESULTS WERE AS FOLLOWS: QA REVIEW ALL PRODUCT RELEASE DATA AND SARA RECORDS FOR LOT 6B03CC AND FOUND NO DEVIATIONS OR DISCREPANCIES. QA REPORTS LOT 6N03CC MET ALL QUALITY AND ANALYTICAL SPECIFICATIONS. AS OF THE OPENING OF THIS COMPLAINT, QA REPORTS THIS COMPLAINT TO BE THE ONLY DEFECTIVE COMPONENT COMPLAINT RECEIVED AGAINST LOT 6B03CC AT THE (B)(4) SITE SINCE THE LOT WAS RELEASE. THE NATURE OF THE COMPLAINT IS THAT THE CONSUMER REPORTS THE SOLUTION POURED OUT OF THE CANISTER DURING THIRD APPLICATION. THE CONSUMER RETURNED 8 APPLICATORS, INSTRUCTION BOOKLET, ONE EMPTY CANISTER, 1 REUSABLE APPLICATOR. THE KIT PACKAGED FOR 12 TREATMENTS. THERE WERE NO VISIBLE DEFECTS TO THE CANISTER. QA NOTES THAT THIS PRODUCT IS SOLD AS A KIT THAT CONTAINS AN INSTRUCTION BOOKLET FOR USE. THE APPLICATOR MUST BE APPLIED CORRECTLY TO THE ACTIVATOR IN ORDER FOR THE PRODUCTS TO DISPENSE. THE CONSUMER'S VERBATIM INDICATED THE PRODUCT WAS USED TWICE WITHOUT ANY ISSUES. IT IS POSSIBLE THAT THE... DEVICE NAME: WART REMOVER. EVALUATION SUMMARY: QA REVIEW ALL PRODUCT RELEASE DATA AND SARA RECORDS FOR LOT 6B03CC AND FOUND NO DEVIATIONS OR DISCREPANCIES. QA REPORTS LOT 6B03CC MET ALL QUALITY AND ANALYTICAL SPECIFICATIONS. AS OF THE OPENING OF THIS COMPLAINT, QA REPORTS THIS COMPLAINT TO BE THE ONLY DEFECTIVE COMPONENT COMPLAINT RECEIVED AGAINST LOT 6B03CC AT THE (B)(4) SITE SINCE THE LOT WAS RELEASED. THE NATURE FOR THE COMPLAINT IS THAT THE CONSUMER REPORTS THE SOLUTION POURED OUT OF THE CANISTER DURING THE THIRD APPLICATION. THE CONSUMER RETURNED 8 APPLICATORS, INSTRUCTION BOOKLET, ONE EMPTY CANISTER, 1 REUSABLE APPLICATOR. THE KIT IS PACKAGED FOR 12 TREATMENTS. THERE WERE NO VISIBLE DEFECTS TO THE CANISTER. QA NOTES THAT THIS PRODUCT IS SOLD AS A KIT THAT CONTAINS AN INSTRUCTION BOOKLET FOR USE. THE APPLICATOR MUST BE APPLIED CORRECTLY TO THE ACTIVATOR IN ORDER FOR THE PRODUCT TO DISPENSE. THE CONSUMER'S VERBATIM INDICATED THE PRODUCT WAS USED TWICE WITHOUT ANY ISSUES. IT IS POSSIBLE THAT THE CONSUMER DID NOT FOLLOW THE PRODUCT INSTRUCTIONS PROPERLY IN USING THE PRODUCT THE THIRD TIME, CAUSING THE PRODUCT TO EMPTY OUT OF THE CANISTER. CONCLUSION: THE COMPLAINT COULD NOT BE VERIFIED. THE CONSUMER RETURNED AN EMPTY CAN OF FREEZE AWAY.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES AS RECEIVED FROM A CONSUMER REFERS TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY INCLUDED REDNESS IN GROIN AREA AND IRRITATION IN GROIN AREA. ON AN UNKNOWN DATE THE PATIENT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), LOT # 6B03CC FOR A WART. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED "CAUSED REDNESS" AND "DID NOT WORK". THE OUTCOME OF "CAUSED REDNESS" AND "DID NOT WORK" IS UNKNOWN. THE REPORTER CONSIDERED "CAUSED REDNESS" AND "DID NOT WORK" TO BE RELATED TO DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER). THE DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) WAS NOT AVAILABLE FOR INVESTIGATION. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL FREEZE AWAY COMMON AND PLANTAR WART REMOVER), THE LOT NUMBER WAS REPORTED AS 6B03CC AND THE SERIAL NUMBER IS NOT AVAILABLE. DID NOT FOLLOW THE PRODUCT INSTRUCTIONS PROPERLY IN USING THE PRODUCT THE THIRD TIME, CAUSING THE PRODUCT TO EMPTY OUT OF THE CANISTER. CONCLUSION: THE COMPLAINT COULD NOT BE VERIFIED. THE CONSUMER RETURNED AN EMPTY CAN OF FREEZE AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283492 DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR UNIT, CRYOSURGICAL, ACCESSORIES (GEH) GEH 6B03CC

    Patients

    Seq Age Sex Outcome Treatment
    1