FDA Adverse Event Injury Summary report: N

CURE CATHETER

MDR report key: 11792974 · Received May 7, 2021

Report

Report Number: 3005471919-2021-00045
Event Type: Injury
Date Received: May 7, 2021
Date of Event: January 8, 2021
Report Date: May 7, 2021
Manufacturer: CURE MEDICAL LLC
Product Code: EZD
PMA / PMN Number: K072539
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRACTICING A CLEAN CATHETERIZATION TECHNIQUE AND STILL GOT A UTI. HE SAID HE DID NOT NOTICE ANY DEFECT, EXPERIENCE ANY MALFUNCTION WITH THE M14 CATHETER, OR NOTICE ANY BREAK IN THE SEAL OF ANY OF THE PACKAGING OR CONTAMINATION BY WATER OR OTHER SUBSTANCE. THE PATIENT WAS INFORMED OF THE STERILIZATION VALIDATION PROCESS AND REASSURED THAT THE PRODUCT SHOULD BE STERILE IF NO BREACH OF PACKAGING OR CONTAMINATION HAPPENED. THE PATIENT REVIEWED HIS CLEAN CATHETERIZATION TECHNIQUE AND SAID HE WOULD FOLLOW IT MORE CLOSELY TO ENSURE HE IS CLEANING THE AREA BEFORE INSERTION AND NOT TOUCHING THE CATHETER AGAINST ANYTHING BEFORE INSERTION. THE PATIENT ALSO PROVIDED A LOT NUMBER 190540-0, BUT THIS LOT NUMBER COULD NOT BE CONFIRMED AS THE LOT NUMBER OF THE M14 CATHETER HE USED AT THE TIME OF THE INFECTION AND DOES NOT MATCH ANY CURE MEDICAL DEVICE LOT NUMBER.

Description of Event or Problem · 1

INTERMITTENT CATHETER PATIENT (USER) SAID HE THINKS THE CATHETERS ARE CONTAMINATED BECAUSE THEY LOOK THE SAME BUT HE'S BEEN GETTING A LOT OF URINARY TRACT INFECTIONS (UTI'S) CONCURRENT WITH CATHETER USE. DURING FOLLOW-UP, THE PATIENT SAID HE HAD NO REPEAT INFECTION AFTER THE INCIDENT AND WOULD KEEP USING THE CATHETER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
689701	CURE CATHETER	URINARY CATHETER	EZD	CURE MEDICAL LLC	M14

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Other