FDA Adverse Event Death Summary report: N

EQUATE

MDR report key: 20350669 · Received October 2, 2024

Report

Report Number
3012316249-2024-00021
Event Type
Death
Date Received
October 2, 2024
Report Date
October 2, 2024
Manufacturer
ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD.
Product Code
ILS
Adverse Event
Yes
Product Problem
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

WALMART REPORT: REFERENCE NUMBER: (B)(4). CUSTOMER STATED : THAT SHE TRIED TO RETURN THE EQ RAISED TOLT SEAT TO THE STORE AND SHE WAS TOLD SHE COULD NOT, CUSTOMER SAYS THAT HER GRANDMOTHER FELL OFF THE SEAT AND HIT HER HEAD WHICH LEAD TO HER DEATH. I ADVISED : THAT THE PRODUCT IS NON RETURNABLE AND WE CANT REFUND , SENDING TO SUPPLIER. ADVISED CUSTOMER THAT SHE CAN FILE A CLAIM BUT SHE SAID ALL THEY WANT IS A REFUND FOR THE PRODUCT THAT THEY CANT USE OFFERED FINAL ASSISTANCE : Y SENT TO SURVEY : Y RESOURCES USED :HTTPS://CENTRALOPS.CUSTHELP.COM/APP/ANSWERS/DETAIL/ A_ID/32414/KW/RELION DOES NOT SEE A LOT NUMBER 06158 TRANSACTION PHONE CALL: GRANDDAUGHTER INDICATED HER GRANDMOTHER HAD VERY ACTIVE DEMENTIA. AMBULANCE PERSONNEL ASSESSED HER AND SAID EVERYTHING WAS FINE. SHE HAD LOST HER BALANCE AND CRACKED THE BACK OF HER SKULL. SHE BLED FOR THE FIRST TIME PER HER GRANDDAUGHTER. SHE TOOK HER TO THE HOSPITAL WHEN SHE NOTICED HER DECLINING. THEY KEPT HER FOR A WEEK. SHE WENT INTO A COMA THE THURSDAY OR FRIDAY BEFORE THE FAMILY HAD AMBULANCE BRING HER HOME WHERE SHE PASSED AWAY. SHE HAD BEEN IN HOSPICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2007174 EQUATE TOILET SEAT WITH ARMS ILS ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD. FGB303EQ WMRT

Patients

Seq Age Sex Outcome Treatment
1 NA Female Death