BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE AQUASONIC 100

    MDR report key: 6211167 · Received December 28, 2016

    Report

    Report Number
    2212018-2016-00001
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 22, 2016
    Report Date
    March 3, 2017
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    IYO
    UDI-DI
    20855683006023
    PMA / PMN Number
    K802146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CONTINUING TO FOLLOW UP WITH THE PHYSICIAN FOR ALLERGIC TESTING RESULTS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 19, 2017 THE ALLERGIST ADVISED THAT THE PATIENT DID NOT COME IN FOR SCHEDULED TESTING ON (B)(6) 2017 AND HAS NOT RESPONDED TO HER FOLLOW UP PHONE CALLS. THEREFORE, NO FURTHER INFORMATION IS AVAILABLE RELATED TO THIS REPORT. AS PREVIOUSLY NOTED, THE ALLERGIST DOES NOT BELIEVE THAT THE STERILE AQUASONIC® 100 THAT WAS USED 45 MINUTES PRIOR TO THE EVENT CAUSED THE ALLERGIC REACTION. THE PATIENT TESTED POSITIVE FOR ALLERGIC RESPONSE TO CHLORHEXIDINE, AND THEIR RESPONSE OCCURRED WITHIN ONE TO TWO MINUTES AFTER THE CHLORHEXIDINE WAS INTRODUCED. PARKER IS NOT AWARE OF ANY RELATED EVENTS.

    Description of Event or Problem · 1

    PARKER LABORATORIES WAS CONTACTED BY AN ALLERGIST WHO REPORTED THAT A PATIENT RECEIVING A CENTRAL VENOUS CATHETER EXPERIENCED ANAPHYLAXIS. STERILE AQUASONIC 100 ULTRASOUND TRANSMISSION GEL HAD BEEN USED ON THE PATIENT DURING AN ECHOCARDIOGRAM ABOUT 45 MINUTES BEFORE THE REACTION TOOK PLACE. WITHIN ONE OR TWO MINUTES AFTER THE INTRODUCTION OF THE LINE, THE PATIENT SAID HE WAS ITCHY, AND DEVELOPED URTICARIA ALL OVER HIS BODY. WITHIN 2 MINUTES HE WAS IN FULL ANAPHYLACTIC SHOCK REQUIRING ADRENALIN, CLEMASTINE, AND STEROIDS. HE NEEDED THE ADRENALINE IV FOR SOME HOURS; HE WAS SEDATED AND INTUBATED. THE ALLERGIST REQUESTED THAT PARKER PROVIDE A LIST OF THE INGREDIENTS OF THE GEL TO EXCLUDE ALL POSSIBLE ALLERGENIC SOURCES FOR THE REACTION. THE LIST WAS PROVIDED. DURING FOLLOW UP EMAILS, THE ALLERGIST ADVISED THAT SHE DOES NOT HAVE THE LOT NUMBER OF THE PRODUCT INVOLVED IN THE EVENT, AS THE PACKAGING HAD ALREADY BEEN DISCARDED. THE GEL APPEARED TO HAVE NORMAL COLOR, ODOR, AND APPEARANCE AT THE TIME OF APPLICATION. PREVIOUSLY KNOWN ALLERGIES FOR THE PATIENT INCLUDE APPLE AND KIWI. THE ALLERGIST ADVISED THAT IN ADDITION TO THE GEL, SHE ALSO CONSIDERED POTENTIAL SOURCES OF THE REACTION TO BE CHLORHEXIDINE, ETHYLENE OXIDE, LATEX, IODINE, AND PEG (SINCE THE PATIENT WAS DIALYSIS DEPENDENT FOR SOME YEARS PRIOR TO THE EVENT). ON (B)(6) 2016, THE DAY FOLLOWING THE EVENT, THE PATIENT WAS STILL INTUBATED AND SEDATED. ON NOVEMBER 30, 2016 THE ALLERGIST PROVIDED THE FOLLOWING UPDATE: THE PATIENT IS DOING WELL. CHLORHEXIDINE IS THE PRIME SUSPECT AT THIS TIME BECAUSE A RADIOALLERGOSORBENT (RAST) HAS RETURNED A POSITIVE RESULT FOR THIS MEDICINE. SHE PLANS TO HAVE THE PATIENT RETURN TO HER OFFICE TO EVALUATE ALL OTHER POSSIBLE CAUSES FOR THE REACTION. AS OF DECEMBER 14, 2016, THE ALLERGIST ADVISED THAT THE TESTING HAD NOT BEEN COMPLETED AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860646 STERILE AQUASONIC 100 ULTRASOUND TRANSMISSION GEL IYO PARKER LABORATORIES, INC. 01-01-4 UNK 20855683006023

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R CHLORHEXIDINE, ETHYLENE OXIDE, LATEX, IODINE, PEG