BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASONIC 100

    MDR report key: 4645770 · Received March 4, 2015

    Report

    Report Number
    2212018-2015-00001
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    December 19, 2014
    Report Date
    February 3, 2015
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    IYO
    PMA / PMN Number
    K802146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED PROD BATCH WAS REVIEWED; IT WAS CONFIRMED THAT SPEC HAD BEEN MET AT THE TIME OF MFG. THE INGREDIENT LIST WAS PROVIDED FOR REFERENCE BY THE PT'S PHYSICIAN PRIOR TO A SCHEDULED BUT UNRELATED SURGERY. WE ARE FOLLOWING UP FOR ADD'L INFO INCLUDING; ANY PRIOR KNOWN ALLERGIES FOR THIS PT, RESULTS OF ANY SKIN PATCH TESTING THAT MAY HAVE BEEN PERFORMED, HAD THE PT BEEN EXPOSED TO THE GET IN THE PAST AND IF SO, WAS THERE A REACTION, PT AGE/DOB, AND WEIGHT. WE HAVE ALSO REQUESTED AN OPPORTUNITY TO EVALUATE THE GET THAT WAS USED AT THE TIME OF THE EVENT; HOWEVER, IT MAY HAVE BEEN CONSUMED BY THE TIME (B)(6) WAS MADE AWARE OF THE EVENT. THE AQUASONIC 100 INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING: CONTRAINDICATION: PTS WITH IMMUNODEFFICIENCY OR IMMUNOSUPPRESSIVE THERAPY. WARNING: DO NOT USE ON PT WITH A KNOWN SENSITIVITY TO PARABENS. THE PT'S HUSBAND HAS ADVISED THAT SHE IS CURRENTLY HOSPITALIZED AS A RESULT OF HER UNRELATED SURGERY. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. OUR REF: (B)(4).

    Description of Event or Problem · 1

    A PT CONTACTED PARKER LABORATORIES' AUTHORIZED REP IN THE (B)(6) AND REPORTED THE FOLLOWING: PT REC'D A SONOGRAM OF THE HEART WHERE THE ULTRASOUND GEL FROM PARKER WAS INVOLVED. ABOUT 30 MINUTES AFTER THIS CHECK UP SHE NOTICED THAT THE SKIN IN THIS AREA WAS RED AND ITCHY. IN ORDER TO ALLEVIATE THE SYMPTOMS SHE PUT ON SOME THIN LOTION ((B)(6)) ON THIS AREA. UNFORTUNATELY, THIS DID NOT HELP. BECAUSE OF THIS SHE REMOVED THE LOTION WITH WATER AND PUT ON FENISTIL HYDROCORT ON THIS AREA. THE REDNESS AND ITCHING WAS STILL THERE AND BECOMES BIGGER AND BIGGER ON THE SKIN. NEXT DAY SHE WENT TO THE DERMATOLOGIST WHICH PRESCRIBED CORTISONE CREME. THIS DID ALSO NOT HELP AND IN ADDITION SHE GOT HOT REDNESS, ITCH AND BRIGHT QUAD SPINDLES ALL OVER HER WHOLE BODY. AT THE END SHE GOT SHORTNESS OF BREATH AND DIFFICULTY IN SWALLOWING. THEREFORE, SHE WAS BROUGHT TO THE (B)(6) HOSPITAL IN (B)(6). THE PHYSICIANS GAVE HER ANTIHISTAMINES AGAINST THESE REACTIONS. THIS TREATMENT HELPED SLOWLY AND IT HEALED UP UNTIL TODAY. THE PT IS ACCORDING TO HER STATEMENT MULTIMORBID BECAUSE SHE IS A STROKE PT AND HAS A KNEE ENDOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150924 AQUASONIC 100 ULTRASOUND TRANSMISSION GEL IYO PARKER LABORATORIES, INC. 01-50 H1044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R