BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN EASE

    MDR report key: 4199377 · Received October 22, 2014

    Report

    Report Number
    1519179-2014-00002
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 21, 2014
    Manufacturer
    GEBAUER CO.
    Product Code
    MLY
    PMA / PMN Number
    K032671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT DESCRIBED IN THIS COMPLAINT IS NOT CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH GEBAUER'S PAIN EASE AND WE HAVE NO SIMILAR COMPLAINTS. GEBAUER CAN NOT DETERMINE IF THIS ADVERSE EVENT IS ASSOCIATED WITH FROSTBITE OR AN ALLERGIC OR NOT RELATED TO OUR PRODUCT AT ALL. TYPICALLY FROSTBITE WOULD BE ASSOCIATED WITH OVER SPRAYING THE PRODUCT BEYOND THE INSTRUCTIONS FOR USE OF 4 TO 10 SECONDS. IT IS HIGHLY UNLIKELY THAT A SINGLE 5 SECONDS SPRAY OF PAIN EASE WOULD RESULT IN THE SERIOUS INJURY DESCRIBED IN THIS COMPLAINT. THE ADVERSE EVENT IS ALSO NOT CONSISTENT WITH AN ALLERGIC REACTION BASED ON TESTING CONDUCTED TO ISO 10993 FOR INTACT SKIN, INTACT MUCOUS MEMBRANES AND MINOR OPEN WOUNDS. BASED ON THIS TESTING, THE PRODUCT IS NOT A DERMAL IRRITANT OR SENSITIZER. THE PATIENT ALSO APPLIED A TOPICAL LIDOCAINE PATCH TO THE INJECTION SITE 5 HOURS AFTER THE INJECTION WHICH MAY HAVE CONTRIBUTED AND OR CAUSED THE ADVERSE EVENT. A REVIEW OF LIDOCAINE PATCH LABELING IDENTIFIES THAT THE APPLICATION SITE MAY DEVELOP BLISTERS, BRUISING, DERMATITIS, EDEMA, PAPULES AND PETECHIA WHICH IS CONSISTENT WITH THE ADVERSE EVENT.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE REACTION THAT RESULTED IN REDNESS, BLISTERING, AND EDEMA, THAT REQUIRED TREATMENT AND RESULTED IN AN OPEN WOUND ON THE KNEE. PATIENT WENT TO HER RHEUMATOLOGIST FOR A CORTISONE INJECTION IN THE KNEE (HAS INJECTION EVERY SIX MONTHS). PHYSICIAN APPLIED PAIN EASE TOPICAL ANESTHESIC SKIN REFRIGERANT TO THE KNEE FOR APPROX 5 SECONDS PRIOR TO PERFORMING THE CORTISONE INJECTION. NO ADVERSE EVENT SYMPTOMS OCCURRED DURING OR IMMEDIATELY FOLLOWING THE INJECTION. APPROX 5 HOURS AFTER THE INJECTION, THE KNEE STARTED TO HAVE PAIN AT THE INJECTION SITE. THE PATIENT APPLIED A TOPICAL LIDOCAINE PATCH TO THE KNEE FOR THE INJECTION SITE PAIN. AROUND 24 HOURS AFTER THE INJECTION THE PATIENT NOTED REDNESS, BLISTERING (LARGE AND SMALL), AND EDEMA COVERING THE ENTIRE SURFACE OF THE KNEE. PHYSICIAN TREATED PATIENT WITH DOXYCYCLINE, BENADRYL, SILVADENE AND SOLUMEDROL DOSE PACK. WOUND ALSO REQUIRED DEBRIDEMENT. SKIN IS HEALING 21 DAYS AFTER INJECTION BUT CENTER OF WOUND IS RAW (3 CM X 1 CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673546 PAIN EASE TOPICAL ANESTHETIC SKIN REFRIGERANT MLY GEBAUER CO. 0386-0008-02/03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention TOPICAL LIDOCAINE PATCH| CORTISONE INJECTION