FDA Adverse Event Injury Summary report: N

NURSE ASSIST, LLC

MDR report key: 19201682 · Received April 29, 2024

Report

Report Number
3002695476-2024-00023
Event Type
Injury
Date Received
April 29, 2024
Report Date
April 24, 2024
Manufacturer
NURSE ASSIST, LLC
Product Code
FRO
UDI-DI
00850421008822
PMA / PMN Number
K083042
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

ON 16-APR-2024 NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FOR THE FOLLOWING EVENT. DESCRIPTION FROM NURSE ASSIST CUSTOMER SERVICE: A PERSON CALLED IN AND SAID THAT SHE/HE USED SALINE, AND IT CAUSED HER/HIM TO GET MULTIPLE INFECTIONS. SHE/HIM USED IT TO USED IT IRRIGATE HER/HIS POUCH (BLADDER MADE OUT OF INTESTINES). SHE SAID SHE TOOK ENOUGH TO FILL THE SYRINGE TO IRRIGATE IT ONCE AND THREW AWAY THE REST. SO, SHE DID INJECT IT INTO HER BODY. THE INFECTION CAUSED IT TO COME OUT LIKE COTTAGE CHEESE WHEN SHE/HE IRRIGATED IT (THAT IS WHAT CAME OUT). SHE/HE HAD THREE BOTTLES LEFT BUT THEY ONLY GAVE ME LOT# ON 2. THE 3RD WAS JUST AN EXPIRATION DATE. LOT# 23045430, 22124487, 1/5/25. NAME: (B)(6) # (B)(6). SHE/HE WANTS TO KNOW WHAT BACTERIA IS IN THE PRODUCT SO SHE CAN TELL DOCTOR SO THEY CAN FIGURE OUT HOW TO TREAT IT. NOTHING THEY ARE DOING IS HELPING GET OVER THE INFECTION. THE PERSON HAS THE POUCH FOR 14 YEARS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1420497 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC 37-6270, 6270 23045430, 22124487 00850421008822

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention