STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER
Received Sep 15, 2014 · Event occurred Nov 1, 2012
Report 1049092-2014-11081 · MDR key 4101798
Device
Generic name
Cement, Stomal Appliance, Ostomy
Manufacturer
Convatec Inc.Model number
183910Catalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Itching Sensation
- Skin Irritation
Narrative
Description of Event or Problem
THE PATIENT REPORTS AN ALLERGY TO THE PRODUCT. THE PATIENT REPORTED HER SKIN BECAME ITCHY AND RED AFTER USING THE PROTECTIVE PASTE. THE PATIENT ALSO INDICATED SHE USES MULTIPLE PRODUCT BRANDS AND CHANGE THE PRODUCTS FREQUENTLY DUE TO THE LOCATION OF THE STOMA. THE PATIENT SOUGHT MEDICAL ATTENTION FROM HER LOCAL PHYSICIAN, HOWEVER, DETAILS REGARDING THE OUTCOME OF THAT APPOINTMENT WERE NOT PROVIDED.
Additional Manufacturer Narrative
ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUES APRIL 16, 2014. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NO DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.