FDA Adverse Event Malfunction Summary report: N

ER MATTRESS

MDR report key: 21834854 · Received April 14, 2025

Report

Report Number
MW5169015
Event Type
Malfunction
Date Received
April 14, 2025
Date of Event
April 4, 2025
Report Date
April 9, 2025
Manufacturer
UNKNOWN
Product Code
QTV
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HUSBAND WENT TO THE EMERGENCY ROOM AT (B)(6) WITH CHEST PAIN. AFTER HIS ELECTROCARDIOGRAM, HE WAS TAKEN TO A ROOM AND GIVEN A GOWN TO CHANGE INTO FOR AN X-RAY. AS HE SAT ON THE BED, HE JUMPED UP WHEN HE FELT FLUID ON HIS PANTS, EXCLAIMING THAT THE BED WAS WET. THE NURSE TOLD HIM IT WAS NOT WET AND HAD JUST BEEN CHANGED. SHE SUGGESTED THAT IF IT WAS WET, HE HAD DONE SOMETHING TO GET IT WET. HE POINTED AT BLOODY WATER ON THE SHEET. HE SAID THE NURSE PALED AND THEN SAID A WOMAN HAD JUST GIVEN BIRTH ON THAT BED. THEY HAD, ACCORDING TO HER, BEEN "HAVING TROUBLE WITH THEIR MATTRESSES." APPARENTLY, THIS MATTRESS ABSORBING THE BLOODY AMNIOTIC FLUID OF THIS WOMAN WAS NOT THE FIRST ISSUE THEY HAD. MY HUSBAND WAS ABSOLUTELY DISGUSTED AND WANTED TO GET HOME TO SHOWER IMMEDIATELY. THE NURSE ASKED HIM TO STAY AND LEFT TO GET THE DOCTOR. THE DOCTOR APOLOGIZED FOR THE BLOOD AND TRIED TO CONVINCE HIM TO STAY. THEY OFFERED HIM SCRUBS TO REPLACE HIS WET, BLOODY JEANS. HE ONLY WANTED TO GET OUT OF THERE, BUT THEY ASKED HIM STAY AND GET A QUICK X-RAY. HE AGREED AND THEY DID ONE IMMEDIATELY. THEN HE DROVE HOME TO SHOWER TO GET THE BLOODY FLUID OFF HIS SKIN. WE ARE BOTH STILL DISGUSTED BY THIS. I REPORTED THIS TO THE HOSPITAL PATIENT RELATIONS SITE WHO SAID THEY WOULD REPLY IN ONE BUSINESS DAY. THREE DAYS LATER, THEY HAVE STILL NOT RESPONDED. APPARENTLY, THE PEOPLE AT (B)(6) ARE NOT AS DISGUSTED AS WE ARE, OR I THINK THEY WOULD HAVE REPLIED BY NOW. CLEARLY, MY HUSBAND IS NOT THE FIRST TO HAVE THIS HAPPEN TO HIM. THE NURSE STATED THAT IT HAS BEEN A PROBLEM. SO, ARE THEY GOING TO ALLOW THIS TO HAPPEN? ARE THEY TAKING STEPS TO PREVENT IT IN THE FUTURE? ARE THE FAULTY MATTRESSES BEING DISCARDED? SHOULD MY HUSBAND BE WORRIED THAT HE HAS BEEN EXPOSED TO BLOOD-BORNE PATHOGENS THAT MAY MAKE HIM ILL? IT SEEMS AS IF (B)(6) ISN'T VERY CONCERNED ABOUT THIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2378716 ER MATTRESS MATTRESS AND BED DECK COVER (MEDICAL PURPOSES) QTV UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 81 YR Male