FLEXI-SEAL SIGNAL FMS

MDR report key: 1931546 · Received December 10, 2010

Report

Report Number: 2243969-2010-00062
Event Type: Injury
Date Received: December 10, 2010
Date of Event: November 15, 2010
Report Date: November 22, 2010
Manufacturer: CONVATEC
Product Code: KNT
PMA / PMN Number: K032734
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

REPORTED BY THE COMPLAINANT AS FOLLOWS: FMS WAS INSERTED WITH BALLOON INFLATED TO UNKNOWN AMOUNT OF FLUID ON THE 8TH OF NOVEMBER DUE TO PATIENT HAVING CONSTANT DIARRHEA OF UNKNOWN ORIGIN CONSISTING OF LIQUID BROWN STOOL. ON THE EVENING OF THE 14TH OF NOVEMBER, PATIENT BEGAN COMPLAINING OF PAIN IN THE RECTAL AREA. SENSI-CARE PROTECTIVE OINTMENT APPLIED TO AREA AROUND ANUS FOR COMFORT. NO BLOODY DISCHARGE WAS RECORDED. FMS REMOVED ON THE 15TH OF NOVEMBER DUE TO CONTINUED COMPLAINT OF DISCOMFORT NO BLOODY DISCHARGE WAS RECORDED. STAFF NURSE CALLED INTO ROOM WITH COMPLAINT OF BOWEL MOVEMENT IN BED. A LARGE BRIGHT RED BLOODY DISCHARGE WITH BLOOD CLOTS PRESENT WAS NOTED BY NURSE. FMS WAS NOT REINSERTED. THE PATIENT WAS GIVEN A COLONOSCOPY WHICH NOTED A PULSATING VESSEL WHICH WAS REPAIRED. EXACT LOCATION OF VESSEL IN COLON UNKNOWN TO CALLER. PATIENT RECEIVED 5 UNITS OF BLOOD. WAS DISCHARGED ON 18TH OF NOVEMBER; DIARRHEA RESOLVED. ADMISSION WAS EXTENDED BY 3 DAYS. PATIENT WAS NOT ADMINISTERED BLOOD THINNERS DURING HOSPITALIZATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXI-SEAL SIGNAL FMS	FECAL MANAGEMENT SYSTEM	KNT	CONVATEC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention