3M¿ RESTON¿ SELF-ADHERING FOAM PADS

Description of Event or Problem

A PARENT REPORTED HER 11 YEAR OLD DAUGHTER DEVELOPED BLISTERS, REDNESS AND SKIN TEAR ON HER FACE AFTER USE OF 3M¿ RESTON¿ SELF-ADHERING FOAM PADS. THE PATIENT WAS UNDERGOING A CRANIOTOMY TO DRAIN A BRAIN TUMOR CYST AND THE PADS WHERE PLACED ON HER CHEEKS AND FOREHEAD FOR CUSHION AND SUPPORT WHILE SHE WAS PRONE POSITIONED FOR TWO HOURS. INITIALLY BOTH CHEEKS HAD BLISTERS, REDNESS AND SKIN TEAR UPON REMOVING THE PADS. THE SIZES WERE APPROXIMATELY 2.5" AND THEN A TEAR DROP SHAPE ABOUT 4-5". THE HOSPITAL SAID IT WAS AN ALLERGIC REACTION AND THAT IT WOULD HEAL. A PLASTIC SURGEON DID FOLLOW UP WITH THE CHILD RIGHT AFTER THE PROCEDURE AND HAS BEEN USING XEROFORM AND AQUAPHOR TO THE AREA. JUNE 10TH THE PLASTIC SURGEON TOLD HER IT TAKES 6-12 MONTHS FOR SCAR TO MATURE AND AT THAT POINT SHE COULD DO A SCAR REVISION OR LASER TREATMENT TO THE AREA.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS. THE DEVICE WAS PLACED DIRECTLY ON THE SKIN; THEREFORE, THIS REPORT IS BEING FILED DUE TO USE ERROR. THERE HAS BEEN NO ADVERSE TREND. SOLVENTUM WILL CONTINUE TO MONITOR. INSTRUCTIONS FOR USE INCLUDE, RESTON SELF-ADHERING FOAM PRODUCTS SHOULD NOT BE PLACED IN DIRECT CONTACT WITH AN OPEN WOUND OR SKIN. SUCH USES CAN RESULT IN DAMAGE TO THE SKIN SUCH AS BLISTERING OR SKIN TEARING WHICH MAY LEAD TO HYPOPIGMENTATION AND THE RISK OF SERIOUS INFECTION.