FDA Adverse Event Other Summary report: N

CARDINAL HEALTH SOLIDIFIER

MDR report key: 23974000 · Received January 6, 2026

Report

Report Number
MW5181779
Event Type
Other
Date Received
January 6, 2026
Date of Event
December 8, 2025
Report Date
December 26, 2025
Manufacturer
CARDINAL HEALTH 200, LLC.
Product Code
GCX
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

I AM WRITING TO ESCALATE A PATIENT SAFETY CONCERN IDENTIFIED IN OUR EMERGENCY DEPARTMENT. RECENTLY, WE HAD AN INCIDENT INVOLVING A SOLIDIFIER PRODUCT. DURING OUR ONGOING INVESTIGATION UNDER JUST CULTURE, IT WAS NOTED THAT THIS BOTTLE DOES NOT HAVE ANY LABELING INDICATING "NOT FOR HUMAN CONSUMPTION." GIVEN THAT THIS PRODUCT MAY BE DISTRIBUTED NATIONWIDE, THIS LABELING ISSUE COULD POTENTIALLY IMPACT OTHER PATIENTS. WHILE OUR INVESTIGATION IS STILL IN PROGRESS, WE BELIEVE IT IS IMPORTANT TO NOTIFY CARDINAL HEALTH AND RELEVANT STAKEHOLDERS PROMPTLY TO MITIGATE ANY FURTHER RISK. DURING THE EVENT, THE RN ADMINISTERED A PATIENT SOLIDIFIER INSTEAD OF THICKENER TO A PATIENT IDENTIFIED AS BEING AT RISK FOR ASPIRATION. THE PATIENT AND FAMILY WERE PROMPTLY INFORMED, AND THE PATIENT REPORTED CONSUMING ONLY A SMALL AMOUNT. THE PATIENT WAS ADMITTED FOR UNRELATED REASONS AND WAS MONITORED THROUGHOUT THE HOSPITALIZATION WITH NO ADVERSE REACTIONS NOTED. PER THE RN'S STATEMENT, SHE WAS UNDER THE IMPRESSION THAT THE SOLIDIFIER WAS EQUIVALENT TO THICKENER AND COULD BE USED FOR UP TO 1200 CC OF LIQUID. SHE FURTHER STATED THAT SHE HAD PREVIOUSLY BEEN INFORMED BY ANOTHER NURSE THAT THE PRODUCT COULD BE USED AS A THICKENER. A 56-YEAR-OLD MALE PATIENT WITH HISTORY OF THYROID ANAPLASTIC THYROID CARCINOMA AND UNDERWENT SURGERY THREE MONTHS AGO TO REMOVE THE RIGHT HALF OF THE THYROID AND A 9 CM ANAPLASTIC THYROID MASS. POST-SURGERY, THE PATIENT BEGAN CHEMOTHERAPY AND RADIOTHERAPY APPROXIMATELY ONE AND A HALF MONTHS AGO, RECEIVING SIX CHEMOTHERAPY SESSIONS AND THIRTY-ONE RADIOTHERAPY SESSIONS. RECENTLY, THE PATIENT'S SKIN BECAME SEVERELY IRRITATED, LEADING TO A RECOMMENDATION TO PAUSE RADIOTHERAPY. THE PATIENT REPORTED INABILITY TO SWALLOW, EVEN WATER, AND HAS EXPERIENCED SIGNIFICANT WEIGHT LOSS, LOSING ABOUT TWO KILOGRAMS OVER A WEEKEND DUE TO THIS ISSUE. THE PATIENT ALSO EXPERIENCED SEVERE SKIN PEELING AND BURNING PAIN, MAKING IT DIFFICULT TO EAT OR DRINK. AN ENT SPECIALIST OBSERVED SIGNIFICANT INFLAMMATION IN THE THROAT AND REFERRED TO THE ED. THE PATIENT ALSO HAD A HISTORY OF COUGHING UP PHLEGM WITH BLOOD, WHICH HAD IMPROVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
45904 CARDINAL HEALTH SOLIDIFIER APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH 200, LLC.

Patients

Seq Age Sex Outcome Treatment
1 56 YR Female Other