FDA Adverse Event Malfunction Summary report: N

FOLYSIL CATHETER

MDR report key: 10286869 · Received July 16, 2020

Report

Report Number: 9610711-2020-00024
Event Type: Malfunction
Date Received: July 16, 2020
Date of Event: June 16, 2020
Report Date: July 16, 2020
Manufacturer: COLOPLAST A/S
Product Code: EZL
UDI-DI: 03600040127490
PMA / PMN Number: K013174
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AFTER RECEIVING THIS COMPLAINT, WE DIDN'T FIND OTHER COMPLAINT ON THIS LOT NUMBER 7396135. THE AA61161002 LOT 7396135 WAS PACKAGED WITH INTERMEDIATE FOLEY AA611680 LOT 7231502. THE AA611680 LOT 7231502 WAS MANUFACTURED WITH DIFFERENT COMPONENTS BALLOON REF YS388260 LOTS 7142031 AND 7142032, VALVE REF ST2012 LOT 1909260042 AND REF YSA16560 LOT 7011850. A PICTURE WAS RECEIVED AND A BALLOON BURST WAS SEEN. SILICONE BALLOON BURSTING COULD COME FROM VARIOUS CAUSES. IN THIS CASES WE CAN NOT IDENTIFY ANY SPECIFIC ROOT CAUSE AS UNSUFFICIENT INFORMATION HAS BEEN PROVIDED TO DO SO. THE SILICONE BALLOON ISSUE IS KNOWN AND FOLLOWED. IN PARALLEL, A SPECIFIC TREND IS MONITORED REGARDING THE SILICONE BALLOON ISSUE.

Description of Event or Problem · 1

ACCORDING TO THE AVAILABLE INFORMATION, BALLOON BURST WAS REPORTED. IN THIS PROCEDURE (LAPAROSCOPIC UTERINE EXTIRPATION), THE UTERUS IS BROUGHT OUT FROM BELOW USING A MANIPULATOR. IT WAS STATED THAT THEY HAVE NEVER HAD ANY PROBLEMS WITH THIS IN THE PAST (LATEX CATHETERS). THE COMPLAINT SAMPLE ITSELF HAS BEEN DISCARDED. NO HARM FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
745916	FOLYSIL CATHETER	FOLEY CATHETER	EZL	COLOPLAST A/S	AA61161002	7396135	03600040127490

Patients

Seq	Age	Sex	Outcome	Treatment
1