FDA Adverse Event Malfunction Summary report: N

THERMASONIC

MDR report key: 20461086 · Received October 16, 2024

Report

Report Number
20461086
Event Type
Malfunction
Date Received
October 16, 2024
Date of Event
June 27, 2024
Report Date
July 10, 2024
Manufacturer
PARKER LABORATORIES INC
Product Code
MUI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT STATED THAT SHE HAD AN ECHOCARDIOGRAM PERFORMED AND WHEN THE SONOGRAPHER PUT THE ULTRASOUND GEL ON HER CHEST, IT WAS PAINFUL. SHE THOUGHT THE SONOGRAPHER MAY HAVE HIT A NERVE WHICH WAS CAUSING PAIN AND DIDN'T STATE ANY ISSUE AT THE TIME. WHEN SHE WENT HOME, SHE DISCOVERED HER SKIN WAS BURNED. THE PATIENT CALLED THE OFFICE AND SPOKE TO SOMEONE ON [REDACTED] AND THAT PERSON SENT ME AN EPIC MESSAGE. I CALLED THE PATIENT. SHE WAS VERY KIND AND TOLD ME WHAT HAPPENED. SHE SAID SHE WOULD UPLOAD A PORTAL MESSAGE TO [REDACTED], HER PCP AT [REDACTED] SO THAT SHE COULD SEE IF THE DOCTOR WOULD RECOMMEND A CREAM OR ANY TREATMENT. SHE STATED SHE DID NOT NEED TO BE SEEN BY THE DOCTOR. I CALLED THE SONOGRAPHER AT (B)(6) WHO WAS WORKING TODAY, AND SHE SAID THE TEMPERATURE ON THE GEL WARMER STATED 43 DEGREES CELSIUS. I LOOKED UP THE CORRECT RANGE OF TEMPERATURE ONLINE AND SAW THAT 40 DEGREES CELSIUS WAS RECOMMENDED SO SHE TURNED IT DOWN TO 40. I FOUND A GEL WARMER AT MY SITE (AMP) THAT WAS AT THE SAME TEMPERATURE AND PUT IT ON MY SKIN. IT WAS HOT, BUT NOT BURNING HOT. THE PATIENT MAY HAVE HAD MORE SENSITIVE SKIN. ANYWAYS, I ALSO CALLED THE SONOGRAPHER WHO PERFORMED THE ECHOCARDIOGRAM ON THIS PATIENT, AND SHE SAID NO PATIENT HAD MENTIONED ANY ISSUE WITH THE TEMPERATURE OF THE GEL OR BEING IN PAIN. I REACHED OUT TO [REDACTED] BEFORE I CALLED THE PATIENT TO MAKE SURE I ASKED THE RIGHT QUESTIONS AND GAVE THE PROPER VERBIAGE. SHE RECOMMENDED I FILL OUT AN OCCURRENCE REPORT. THE GEL WARMERS DO NOT HAVE BIOMED STICKERS AND AREN'T CHECKED BY THEM. THE MODEL NUMBER IS 83-03 BY PARKER LABORATORIES INC. 120V 60HZ 31W. THE SN IS [REDACTED].

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1352497 THERMASONIC MEDIA, COUPLING, ULTRASOUND MUI PARKER LABORATORIES INC 83-03

Patients

Seq Age Sex Outcome Treatment
1 74 YR Unknown Other