STOMAHESIVE PASTE (1TUBEX56.7G) US
Received Nov 7, 2013 · Event occurred Feb 27, 2013
Report 1049092-2013-00190 · MDR key 3476734
Device
Generic name
Protector, Ostomy
Manufacturer
Convatec Inc.Model number
183910Catalog number
183910
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Skin Inflammation
Narrative
Description of Event or Problem
AN END USER CALLED IN AND STATED HE BELIEVES HE'S EXPERIENCING CONTACT DERMATITIS TO HIS PERISTOMAL SKIN IN THE AREA WHERE THE STOMAHESIVE PASTE HAD BEEN APPLIED. THE END USER STATED IT BEGAN ABOUT NINE (9) MONTHS AGO AND WENT ON TO STATE THE AREA HAS NOT GOTTEN BETTER OR WORSE.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED HE SAW AN ALLERGIST WHO PREFORMED A SKIN PATCH TEST. THE END USER ALSO REQUESTED A LIST OF INGREDIENTS IN THE PRODUCT AND THE MATERIAL SAFETY DATA SHEET (MDS) WAS PROVIDED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED.