EQUATE

Description of Event or Problem

ACCORDING TO THE INITIAL REPORT RECEIVED BY THE FDA ON JANUARY 12, 2026, A CONSUMER FILED A VOLUNTARY MDR (REPORT #MW5180820). THE CONSUMER STATED THAT SHE USED THE PRODUCT TO COVER A SPOT ON HER SON'S FACE TO PREVENT INFECTION. THE FOLLOWING DAY, THE DAYCARE SENT A PHOTOGRAPH SHOWING THAT THE SKIN WHERE THE BANDAGE HAD BEEN APPLIED WAS "BUBBLED UP." THE CONSUMER STATED THAT THE BANDAGE CAUSED A CHEMICAL BURN. ON THE COMPLETED CONSUMER INFORMATION REQUEST FORM (CIR) RECEIVED ON FEBRUARY 06, 2026, THE CONSUMER STATES THAT HER SON HAD A BLEMISH ON FACE AND SHE USED THE BANDAGE TO COVER IT. A DAY LATER, HIS FACE WAS BUBBLED/BLISTERED. THE PATIENT WAS EVALUATED BY A PEDIATRICIAN, WHO PRESCRIBED AN ANTIBIOTIC AND A STEROID OINTMENT. THE CONSUMER SPECIFIED THE REACTION OCCURRED IN THE AREA OF THE ADHESIVE TAPE. WHILE THE CONSUMER CONFIRMED THAT SYMPTOMS IMPROVED AFTER DISCONTINUING PRODUCT USE, SHE NOTED THAT THE AREA IS NOT YET FULLY HEALED.

Additional Manufacturer Narrative

AS OF 03/03/2026 ASO PERFORMED TESTING WITH RETAINED SAMPLES AND REVIEWED RECORDS OF SATISFACTORY BIOCOMPATIBILITY TESTS FOR THIS TYPE OF PRODUCT WITH NO ISSUES NOTED. REFER TO SECTION B6 OF THIS REPORT FOR FURTHER DETAILS.