FDA Adverse Event Death Summary report: N

VICKS

MDR report key: 13388823 · Received January 28, 2022

Report

Report Number
1314800-2022-00005
Event Type
Death
Date Received
January 28, 2022
Report Date
January 28, 2022
Manufacturer
KAZ USA, INC., A HELEN OF TROY COMPANY
Product Code
KFZ
UDI-DI
00328785001365
PMA / PMN Number
EXEMPT
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
003

Narratives

Additional Manufacturer Narrative · 0

KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

Description of Event or Problem · 0

A CONSUMER REPORTED THAT HER HUSBAND HAD BEEN USING A VICKS WARM MIST HUMIDIFIER IN CONJUNCTION WITH VICKS VAPOSTEAM AND VICKS VAPOPADS IN THE SPRING OF 2020 WHILE HE WAS DIAGNOSED WITH COVID-19. SHE STATED THAT HER HUSBAND PASSED AWAY DUE TO COMPLICATIONS RELATED TO COVID-19 INFECTION, AND ALLEGES THAT ONE OF THE DOCTORS WHO HAD BEEN TREATING HIM BELIEVES THAT THE USE OF VAPOSTEAM MAY HAVE CONTRIBUTED TO HIS RESPIRATORY ISSUES AND DECREASED HIS CHANCE OF RECOVERING. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE WOMAN STATED THAT SHE HAD SINCE GIFTED THE HUMIDIFIER TO A FAMILY FRIEND AND WAS UNSURE WHETHER SHE COULD GET IT BACK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1363383 VICKS WARM MIST HUMIDIFIER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY VWM845 UNKNOWN 00328785001365

Patients

Seq Age Sex Outcome Treatment
1 Male Death