FDA Adverse Event Malfunction Summary report: N

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

MDR report key: 4088251 · Received August 1, 2014

Report

Report Number: 1049092-2014-00371
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 14, 2014
Report Date: July 14, 2014
Manufacturer: CONVATEC, INC.
Product Code: KNT
PMA / PMN Number: K032734
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: NURSE

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. IT IS UNKNOWN HOW LONG THE PRODUCT WAS INSERTED AND WHETHER IT WAS REMOVED AND REINSERTED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW[-UP REPORT WILL BE SUBMITTED. PLEASE NOTE: THERE ARE TWO (2) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE, A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. 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 THE BALLOON WAS OVERINFLATED WITH 75CC OF FLUID, RESULTING IN EXCESS FLUID BEING REMOVED FROM BALLOON AND NO UNTOWARD EFFECT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451858	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT		KNT	CONVATEC, INC.	418000	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1