FDA Adverse Event Malfunction Summary report: N

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

MDR report key: 3921528 · Received June 9, 2014

Report

Report Number: 1049092-2014-00181
Event Type: Malfunction
Date Received: June 9, 2014
Date of Event: May 13, 2014
Report Date: May 13, 2014
Manufacturer: CONVATEC INC.
Product Code: KNT
PMA / PMN Number: K032734
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL DATED 05/15/2014 IS STATED AS FOLLOWS: "THE SYSTEM WAS NOT CLOSED, THE STOOL WENT BACK THROUGH THE SIGNAL INDICATOR AND COULD NOT GET OUT DUE TO BEING BLOCKED. I CHANGED THE SYSTEM WITH A NEW ONE. IT WAS NOT A USER PROBLEM, THE SYSTEM WAS DEFAULT." NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

Description of Event or Problem · 1

IT IS REPORTED THAT THE FMS BALLOON LEAKED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
335008	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT	GASTROINTESTINAL TUBE AND ACCESSORIES	KNT	CONVATEC INC.	418000	13VM517411

Patients

Seq	Age	Sex	Outcome	Treatment
1