NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER

Report

Report Number: 1049092-2014-00319
Event Type: Injury
Date Received: July 18, 2014
Date of Event: June 14, 2014
Report Date: June 27, 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 END-USER CURRENT POUCH USED IS CONVATEC'S PRODUCT# 401512 (SUR-FIT DRAINABLE POUCH - TRANSPARENT WITH 1-SIDED COMFORT PANEL - FLANGE SIZE: 1 3/4" (45MM) WHICH IS USED WITH CONVATEC'S PRODUCT#: 183910 (STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER) WITH WAFER CHANGES EVERY THREE (3) TO FOUR (4) DAYS. LASTLY, ALTERNATE PRODUCT SAMPLES SENT TO END-USER. 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. 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 END-USER DEVELOPED A RED RASH UNDER THE OSTOMY TAPE COLLAR AFTER THREE (3) TO FOUR (4) DAYS OF USE. IT IS FURTHER REPORTED THAT END-USER WAS SEEN BY AN OSTOMY NURSE IN EMERGENCY ROOM ON (B)(6) 2014 WHO PRESCRIBED NYSTATIN POWDER AND SKIN PREP TO AFFECTED AREA WITH EACH WAFER CHANGE, AND ALSO RECOMMENDED CONVATEC'S PRODUCT# 413187 (SUR-FIT NATURA DURAHESIVE SKIN BARRIER WITH PRE-CUT OPENING, AND WHITE TAPE COLLAR - STOMA SIZE 1 3/4" (45MM)).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
423087	NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER	PROTECTOR, OSTOMY 78EXE	EXE	CONVATEC INC.	413183	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention