ESENTA STING-FREE ADHESIVE REMOVER WIPE

Description of Event or Problem

PATIENT CALLED TO REPORT AN ADVERSE REACTION AND PRODUCT PROBLEM REGARDING 2 DEVICES SHE USES FOR HER OSTOMY BAG. THE TWO DEVICES ARE SKIN BARRIER WIPES AND ADHESIVE REMOVER WIPES BOTH OF WHICH THE PATIENT STATED SHE HAS USED FOR OVER 2 YEARS WITHOUT ANY ISSUES. PATIENT STATED THIS MONTH¿S SHIPMENT OF THE DEVICES BOTH HAD A HORRIFIC SMELL LIKE CAT URINE WHICH WAS NOT NORMAL. PATIENT STATED HER SKIN IS IRRITATED WITH SORES AND OPEN LESIONS THAT ITCH WHERE SHE USES THE WIPES. PATIENT STATED HER SKIN LOOKS BURNED AND THE AREA DOES STING WHEN THE WIPES ARE APPLIED WHEN NORMALLY THEY NEVER STING HER SKIN. PATIENT ALSO STATED THE WIPES AREN¿T WORKING AS WELL AND SHE HAS TO SCRUB A LITTLE HARDER THAN NORMAL. PATIENT STATED SHE IS CONCERNED AS THESE WIPES SHOULD BE STING FREE AND SHOULD NOT CONTAIN ANY CHEMICALS THAT WOULD CAUSE STINGING. PATIENT MENTIONED SHE IS SENSITIVE TO AMMONIA. PATIENT SAID THE SCENT OF THE WIPES IS SO STRONG IT BURNS THE BACK OF HER THROAT. SHE STATED SHE REACHED OUT TO THE MANUFACTURER WHO IS SENDING HER A NEW SHIPMENT OF SUPPLIES. PATIENT STATED THE MEDICAL SUPPLIER IS (B)(4). REFERENCE REPORT MW5166459.