Description of Event or Problem · 0
A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE PATIENT EXPERIENCED A SKIN REACTION WHILE USING 4X4 ISLAND DRESSINGS. SHE STATED THAT THE DRESSINGS CAUSED THE PATIENT¿S SKIN TO BECOME RED, ITCHY, AND IRRITATED. ACCORDING TO THE PATIENT¿S WIFE, THE CLINIC PROVIDED TEGADERM AS AN ALTERNATIVE; HOWEVER, AFTER USING IT, THE PATIENT¿S SKIN AGAIN BECAME RED, AND A WATER BLISTER DEVELOPED. THE PATIENT HAS A SCHEDULED DOCTOR¿S APPOINTMENT NEXT WEEK, DURING WHICH THEY PLAN TO CONSULT THE NURSE REGARDING APPROPRIATE ALTERNATIVES TO PREVENT FURTHER SKIN IRRITATION, AN RGA (RETURN GOODS AUTHORIZATION) WAS NOT REQUIRED FOR THE TEGADERM, AS IT IS NOT LISTED ON THE PATIENT¿S PRESCRIPTION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).