ECOVUE ULTRASOUND GEL

Description of Event or Problem

(B)(6), A MEMBER OF (B)(6) IN (B)(6), EXPERIENCED 21 EVENTS INVOLVING 20 PATIENTS WITH THE USE OF ECOVUE ULTRASOUND GEL (MANUFACTURER: HR PHARMACEUTICALS, INC.) DURING OBSTETRICAL ULTRASOUNDS (US) OVER A 6-MONTH PERIOD (B)(6) 2025). OF THESE, 13 OCCURRED IN THE AREA OF MATERNAL FETAL MEDICINE (MFM) AND THE REMAINING 8 OCCURRED IN LABOR & DELIVERY/ POST-PARTUM. THE REACTIONS RANGED FROM MILD ITCHY RED RASH/ HIVES TO EXTREME REDNESS COVERING THE ENTIRE ABDOMEN WITH AREAS OF EXCORIATION AND PAINFUL TO TOUCH. SOME REACTIONS WERE IMMEDIATE AND OTHERS WERE DELAYED. TREATMENT RANGED FROM NO TREATMENT/CLEANSING THE ABDOMEN TO TOPICAL STEROIDS AND ORAL ANTIHISTAMINES. NO PERMANENT HARM RESULTED FROM THESE EVENTS. THE PRODUCT MANUFACTURER HAS BEEN NOTIFIED ABOUT THESE EVENTS. NO TESTING DONE BY HOSPITAL. PATIENT: 1943, 2033, 1840, 1994. DEVICE: 2682. REFERENCE REPORTS: MW5181141, MW5181142, MW5181143, MW5181144, MW5181145, MW5181147, MW5181148, MW5181149, MW5181150, MW5181151, MW5181152, MW5181153, MW5181154, MW5181155, MW5181156, MW5181157, MW5181158, MW5181159, MW5181160, MW5181161.