BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN EASE

    MDR report key: 5154237 · Received October 15, 2015

    Report

    Report Number
    1519179-2015-00002
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    October 15, 2015
    Manufacturer
    GEBAUER COMPANY
    Product Code
    MLY
    PMA / PMN Number
    K032671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE TEST RESULTS THAT INDICATE THAT THE DEVICE MEETS THE REQUIREMENTS FOR COMPOSITION AND PURITY, THERE APPEARS TO BE NO PRODUCT MALFUNCTION OR DEFECT. ALSO, BASED ON THE AMOUNT OF PRODUCT LEFT IN THE CAN, THE PRODUCT WAS MOST LIKELY USED ON OTHER PATIENTS WITH NO ADVERSE REACTION. THE MOST LIKELY CAUSES OF THE PROBLEM MAY BE FROSTBITE DUE TO OVER SPRAYING, THE DIABETIC CONDITION OF PATIENT OR NOTHING TO DO WITH DEVICE. THE REPORTER INDICATES SPRAYING THE PRODUCT IN ACCORDANCE WITH INSTRUCTIONS FOR USE BUT THIS CAN'T BE CONFIRMED. PREVIOUS PRODUCT COMPLAINTS FOR FROSTBITE HAVE BEEN ASSOCIATED WITH OVER SPRAYING. ASSUMING THE PRODUCT WAS APPLIED CORRECTLY THE DIABETIC CONDITION OF THE PATIENT MAY HAVE CAUSED THE ADVERSE REACTION TO THE PRODUCT. BOTH OVER SPRAYING AND NOT USING THE PRODUCT ON PERSONS WITH POOR CIRCULATION ARE ADDRESSED ON THE PRODUCT'S INSTRUCTIONS FOR USE. OTHER PRODUCTS WERE APPLIED TO THE PATIENT DURING THE PROCEDURE WHICH ALSO COULD HAVE CAUSED THE ADVERSE REACTION.

    Description of Event or Problem · 1

    THE PATIENT (MALE) WAS BEING TREATED BY THE INITIAL REPORTER FOR INGROWN TOE NAIL REMOVAL. THE PATIENT HAD PAIN EASE APPLIED TO THE 5TH DIGIT OF THE RIGHT FOOT PRIOR TO THE INGROWN TOE NAIL REMOVAL PROCEDURE ON (B)(6) 2015. THE REPORTER IDENTIFIED THAT PAIN EASE WAS APPLIED FOR APPROXIMATELY 5 SECONDS FROM 2 TO 3 INCHES AWAY FROM THE 5TH DIGIT IN ACCORDANCE WITH THE PRODUCT'S INSTRUCTIONS FOR USE. PAIN EASE WAS APPLIED AS A TOPICAL ANESTHETIC PRIOR TO THE MINOR SURGICAL PROCEDURE. THE PATIENT IS A DIABETIC. THE REPORTER DOES NOT BELIEVE THAT PAIN EASE WAS PREVIOUSLY USED ON THE PATIENT. THE REPORTER DID NOT NOTE ANY ADVERSE REACTION AT THE TIME OF THE PROCEDURE. IN ADDITION TO USING PAIN EASE, FUDES SPRAY, 70% RUBBING ALCOHOL AND POLYSPORIN WERE APPLIED TO THE AFFECTED TOE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT 5 DAYS AFTER THE INGROWN TOE NAIL REMOVAL PROCEDURE ((B)(6) 2015). THE TOE THAT HAD THE PROCEDURE PERFORMED ON IT HAD BROKEN SKIN/BROKEN BLISTER(S) WITH REDNESS AND SWELLING. AS DESCRIBED, THE PATIENT WAS EXPERIENCING SIGNIFICANT PAIN AND HAVING DIFFICULTY WALKING. THE EMERGENCY DEPARTMENT TREATED THE PATIENT WITH AN ANTIBIOTIC DRESSING AND REQUIRED THE PATIENT TO RETURN FOR FREQUENT DRESSING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683677 PAIN EASE TOPICAL ANESTHETIC SKIN REFRIGERANT MLY GEBAUER COMPANY 0386-0008-03 6337

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention