OTHER ACCESSORIES

Additional Manufacturer Narrative

A2: AGE AT THE TIME OF EVENT - 35 YEARS. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 1000317571.

Description of Event or Problem

THE END USER REPORTED THAT HE HAD SKIN IRRITATION WITH ONE OSTOMY SUPPORT BELT WHICH STARTED THREE YEARS AGO WITH 2 X 4" PERSISTENT RED PATCH UNDER A SECTION OF THE BELT. NO TREATMENT OR DIAGNOSIS WAS PROVIDED AT THAT TIME. HOWEVER, PRIMARY CARE PHYSICIAN (PCP) THOUGHT HE HAD NOW DEVELOPED A SECONDARY FUNGAL INFECTION OR CONTACT DERMATITIS UNDER THE BELT. HE ALSO REPORTED THAT A LINEAR REDDENED AREA OF IRRITATION UNDER THE ENTIRE LOWER EDGE OF THE BELT WHICH SOMETIMES ITCHES. HE DISCONTINUED THE BELT AND SWITCHED TO AN OSTOMY ARMOR SHIELD. AFTER THE BELT WAS REMOVED, THE END USER EXPERIENCED SOME RELIEF. FURTHERMORE, THE PRIMARY CARE PHYSICIAN (PCP) TREATED HIM WITH ORAL FLUCONAZOLE (DIFLUCAN). HE ALSO STARTED SELF-MEDICATING WITH PREDNISONE TO ALLEVIATE THE ITCHING AND PERSISTENT REDNESS. FOLLOW-UP APPOINTMENTS WITH THE PCP AND DERMATOLOGY HAD BEEN SCHEDULED FOR FURTHER TESTING THE COMING WEEK. THE END USER MENTIONED THAT THEY TYPICALLY WEAR THE BELT FOR TWENTY-FOUR HOURS, EXCEPT DURING SHOWERING AND STATED THAT HE WAS NOT WEARING THE BELT TOO TIGHTLY. HE ALSO WORKS OUTDOORS AND REPORTED THAT MOISTURE COULD BE A FACTOR. HE TRIES TO KEEP SKIN DRY. NO OTHER SKIN CONCERNS WERE REPORTED, OTHER THAN JUST UNDER THE BELT. ADDITIONALLY, THERE WERE NO CONFIRMED ALLERGENS. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.