STERILE AQUASONIC ULTRASOUND TRANSMISSION GELRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20855683006023), received between Dec 28, 2016 and Dec 28, 2016 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 C

  Patient problems: Anaphylactoid / Anaphylaxis; Urticaria

  MAUDE report 6211167 ↗