NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER

Report

Report Number: 1049092-2014-00251
Event Type: Injury
Date Received: June 30, 2014
Date of Event: June 5, 2014
Report Date: June 5, 2014
Manufacturer: CONVATEC, INC.
Product Code: EXE
PMA / PMN Number: K855018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT THE PRODUCT WAS IN USE FOR THREE (3) DAYS BEFORE THE ISSUE OCCURRED; IN ADDITION END-USER WAS ADVISED TO CHANGE WAFER STOMA SIZE, AND A ONE INCH SIZED CONVEX PRODUCT WAS RECOMMENDED FOR USE. LASTLY, END-USER WAS PROVIDED INSTRUCTIONS IN CRUSTING TECHNIQUES. 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. REPORTED TO THE FDA ON (B)(6) 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 THAT A WEEK AGO, END-USER DEVELOPED SKIN IRRITATION; BLISTERING AND ITCHING ON THE ABDOMEN AROUND THE STOMA RELATED TO OSTOMY USE. THE END-USER SAW HER OSTOMY NURSE WHO PRESCRIBED AN ANTI-FUNGAL POWDER WHICH SHE HAS BEEN APPLYING SINCE (B)(6) 2014 TO THE AFFECTED SITE, AND THE AREA HAS IMPROVED AS A RESULT. IT IS FURTHER REPORTED THAT HER OSTOMY NURSE ADVISED HER THAT THE AREA DEVELOPED, BECAUSE SHE HAD BEEN ON AN ANTIBIOTICS AND HER WAFER HAD BEEN LEAKING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379035	NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER	PROTECTOR, OSTOMY 78EXE	EXE	CONVATEC, INC.	413182	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention