FDA Adverse Event Injury Summary report: N

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

MDR report key: 3850482 · Received May 20, 2014

Report

Report Number: 1049092-2014-00125
Event Type: Injury
Date Received: May 20, 2014
Date of Event: April 24, 2014
Report Date: April 25, 2014
Manufacturer: CONVATEC INC.
Product Code: KNT
PMA / PMN Number: K032734
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON THE REPORTS OF EVIDENCE OF AN ULCERATION WHERE BALLOON SITS AND THE SOURCE OF THE BLEEDING. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. (B)(4). 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 WAS INSERTED ON THE PATIENT WITH MULTIPLE MEDICAL ISSUES AND ON A VENTILATOR. THE FMS WAS INSERTED RELATED TO DIARRHEA UPON ADMISSION, THE PATIENT DEVELOPED A GI BLEED DURING USE RESULTING IN THE TRANSFUSION OF TWO (2) UNITS OF BLOOD. A GI SCOPE IDENTIFIED AN ULCERATION WHERE BALLOON SITS AND THE SOURCE OF THE BLEEDING. IT IS ALSO REPORTED THAT THE BALLOON WAS INFLATED WITH 40-45 MLS, AND THE FLEXISEAL HAD BEEN IN FOR ABOUT 14 DAYS. PATIENT IS STABLE AND REMAINS IN ICU.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298994	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT	GASTROINTESTINAL TUBE & ACCESSORIES 78	KNT	CONVATEC INC.	418000	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention