BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASONIC 100 ULTRASOUND GEL

    MDR report key: 2954219 · Received February 8, 2013

    Report

    Report Number
    2212018-2013-00001
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    MUI
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT RECEIVED FROM PATIENT ON (B)(6) 2013. HIPAA CONFIDENTIAL INFORMATION RECORDED ON COMPLAINT (B)(6) AT PARKER LABORATORIES. AQUASONIC 100 ULTRASOUND GEL IS AVAILABLE IN FIVE DIFFERENT SIZES; 01-20 IS A 20ML SINGLE USE PACKETTE, 01-02 IS A 60G TUBE, 01-08 IS A 250 ML DISPENSER, 01-34 IS A 1 LITER BOTTLE AND 01-50 IS A 5 LITER CONTAINER. IT IS UNKNOWN WHICH SIZE OR LOT NUMBER WAS USED DURING THIS PROCEDURE AND THE 01-08 SIZE WAS USED IN THIS REPORT BECAUSE IT IS A COMMON PACKAGE SIZE.

    Description of Event or Problem · 1

    PARKER LABORATORIES QUALITY ASSURANCE DEPARTMENT (B)(4) RECEIVED A PHONE CALL FROM PATIENT '(B)(6)' ON (B)(6) 2013. ON (B)(6) 2013, (B)(6) RECEIVED A TRANSVAGINAL ULTRASOUND AT (B)(6) WHERE PARKER LABORATORIES'S AQUASONIC 100 ULTRASOUND GEL (REF 01-08) WAS USED. LATER THAT DAY (B)(6)'S HUSBAND (B)(6) DEVELOPED HIVES AND ANAPHYLACTIC SHOCK (VOMITING, SWEATING) AFTER INTERCOURSE WITH (B)(6). (B)(6) REPORTED THAT (B)(6) HAS ALLERGIES TO PENICILLIN, STRAWBERRIES AND ALL NON-STEROIDAL ANTI-INFLAMMATORIES. (B)(6) REPORTED THAT (B)(6) HAD EPINEPHRINE BENADRYL STEROIDS PRESCRIBED BY 'AMBULATORY CARE' (B)(6) AND WAS HOME AND OK. ON (B)(6) 2013, DURING A FOLLOW-UP PHONE CALL BY PARKER'S (B)(6), (B)(6) CONFIRMED AGAIN THAT (B)(6) WAS OK. ON (B)(6) 2013, PARKER QA MANAGER (B)(4) TALKED WITH RISK MANAGER, (B)(6). (B)(6) DESCRIBED U/S PROCEDURE AS USING A LATEX CONDOM SHEATH ON THE U/S PROBE WITH AQUASONIC 100 GEL. IT IS NOT CLEAR IF THE GEL WAS ON BOTH THE INSIDE AND OUTSIDE OF THE LATEX CONDOM. (B)(6) WAS AWARE OF (B)(6)'S ALLERGIC REACTION BUT IDENTIFIED THAT THE PATIENT, (B)(6), WAS THEIR CONCERN AND RESPONSIBILITY. (B)(6) REPORTED THAT THEY DID NOT INTEND TO FILE A FORM 3500A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53466 AQUASONIC 100 ULTRASOUND GEL MUI, ULTRASOUND GEL MUI PARKER LABORATORIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening