FLEXI-SEAL SIGNAL FMS

MDR report key: 1882441 · Received October 21, 2010

Report

Report Number: 2243969-2010-00046
Event Type: Death
Date Received: October 21, 2010
Date of Event: September 21, 2010
Report Date: September 23, 2010
Manufacturer: CONVATEC
Product Code: KNT
PMA / PMN Number: K032734
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). FDA REGISTRATION NUMBER: REPORTING SITE (SPECIFICATION DEVELOPER): 2243969. MANUFACTURING SITE: 1049092.

Description of Event or Problem · 1

REPORTED BY THE COMPLAINANT AS FOLLOWS: FMS INSERTED (B)(6). ON (B)(6), A WOUND AT OPENING OF ANUS, LOCATED ALL AROUND THE TUBING (ALL AROUND ANAL OPENING) WAS NOTICED. CLINICAL EDUCATOR STATES: THIS IS THE WORSE WOUND SHE HAS SEEN DEVELOP FROM A FECAL MANAGEMENT DEVICE IN HER CAREER, AND WANTS THIS FACT KNOWN. SHE ALSO STATES THE WOUND WAS AT A STAGE OF NECROSIS. SHE CANNOT SAY IF STAFF HAD PERFORMED ALL WOUND PREVENTION MEASURES (TURNING PATIENT Q2HRS AS PER PROTOCOL, HAVE THERE BEEN LEAKS PRIOR, ETC¿). THEY DID NOT DISCONTINUE USE OF FMS, AS PATIENT WAS C-DIFF AND WITH DIARRHEA +++ PATIENT DECREASED (B)(6). KNOWN FOR SMALL CELL LUNG CA, C-DIFF COLITIS, PNEUMONIA, AS A RESULT OF PNEUMONIA, DEVELOPED PSEUDOMONAS, THEN WENT SEPTIC AND DIAGNOSIS WAS THAT HE EXPIRED DUE TO THE SEPSIS. WAS ON IV NOREPINEPHRINE.

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			Death