SUR-FIT NATURA 2PC DURAHESIVE CONVEX WAFER

Report

Report Number: 1049092-2014-00067
Event Type: Injury
Date Received: March 6, 2014
Date of Event: February 11, 2014
Report Date: February 11, 2014
Manufacturer: CONVATEC INC.
Product Code: EXE
PMA / PMN Number: K855018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED IT WAS A HOT SUMMER WHEN THE ISSUE OCCURRED. THE AREA WAS EVALUATED BY AN OSTOMY NURSE AND A PHYSICIAN. SHE WAS PLACED ON ANTIBIOTICS AND ANTI-FUNGAL TOPICALS. THE END USER DID NOT PROVIDE PRODUCT INFORMATION ON THE ANTIBIOTICS AND ANTI-FUNGAL TOPICALS USED FOR TREATMENT. THE END USER REPORTS IT TOOK ABOUT SIX MONTHS TO HEAL THE AREA. SHE STATED THE AREA IS HEALED NOW AND SHE STILL USES THE SAME WAFER BUT, CUTS THE TOP COLLAR OFF. IT WAS SUGGESTED THAT THE END USER USE A DIFFERENT SYSTEM WITH ACRYLIC TAPE COLLAR; CUT A SMALL PIECE OF THE TAPE COLLAR OFF AND WEAR TO EVALUATE FOR ANY SKIN SENSITIVITY. SHE WAS ALSO RECOMMENDED TO USE STOMAHESIVE STRIPS TO SKIN. NO ADDITIONAL EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD PATIENT/EVENT DETAILS BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

Description of Event or Problem · 1

END USER REPORTS OVER THE SUMMER OF 2012 SHE DEVELOPED REDNESS BENEATH THE TAPE COLLAR AFTER SHE HAD REMOVED THE WAFER. END USER COULD NOT PROVIDE THE EXACT DATE INFORMATION OF THE INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
134214	SUR-FIT NATURA 2PC DURAHESIVE CONVEX WAFER	PROTECTOR, OSTOMY	EXE	CONVATEC INC.	413181	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention