BAND-AID HYDROCOLLOID

Additional Manufacturer Narrative

THIS FOREIGN REPORT IS BEING SUBMITTED ON 04-MAY-2016 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (BAB ADV HEALING BLISTER FINGER TOE 8S). THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 9610694-2016-00102. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 9610694-2016-00101. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

Description of Event or Problem

THIS SPONTANEOUS REPORT WAS RECEIVED ON 06-APR-2016 FROM A (B)(6) MALE CONSUMER REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2016, THE CONSUMER STARTED USING BAND-AID KPP JUMBO 3 2013, CUTANEOUSLY, FOR TWO TO THREE DAYS, TO HEAL A TWO-CENTIMETERS SIZED SHALLOW WOUND WITH INFECTION (USED FOR A DIRTY WOUND) BETWEEN THE WRIST AND THE ELBOW (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER TWO TO THREE DAYS OF USAGE IN 2016, HE DEVELOPED DISCOMFORT AND REDNESS AROUND THE WOUND, THE WOUND SMELLED BAD, AND THE DEVICE WAS REPLACED WITH A NEW ONE. ON (B)(6) 2016, HE VISITED HOSPITAL AND CONSULTED AN ORTHOPEDIST, PLASTIC SURGEON, AND DERMATOLOGIST WHO TOLD HIM THE SKIN OF THE AFFECTED AREA HAD BECOME NECROTIC AND SKIN GRAFTING WOULD BE REQUIRED. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENT DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.