SOFT SHELLS FOR INVERTED NIPPLES

Description of Event or Problem

THE CUSTOMER CONTACTED CUSTOMER SERVICE TO INQUIRE ABOUT WHAT THE SOFT SHELLS ARE MADE OF, AS SHE HAD DEVELOPED A RASH AFTER USING THEM.

Additional Manufacturer Narrative

THE CUSTOMER WAS ADVISED THAT THE SOFT SHELLS ARE MADE OF SILICONE. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT AFTER USING THE SOFT SHELLS FOR ONE DAY, SHE DEVELOPED A RASH THAT LOOKED LIKE LITTLE BLISTERS WHICH WERE EXTREMELY ITCHY. THE RASH WAS ON BOTH BREAST WHERE THE SOFTWARE SHELLS MADE CONTACT WITH HER SKIN. SHE WAS PRESCRIBED A 2.5% STRENGTH CORTISONE CREAM. SHE DISCONTINUED USE OF THE SOFT SHELLS AND USED THE CORTISONE CREAM FOR A SHORT TIME, BOTH AFTER WHICH THE RASH AND ITCHING STARTED TO SUBSIDE. SHE ALSO INDICATED THAT SHE RECENTLY DISCOVERED THAT SHE HAS AN ADHESIVE ALLERGY AFTER A REACTION TO TAKE THAT WAS USED DURING HER C-SECTION. THE CUSTOMER CONFIRMED THAT SHE WOULD RETURN THE SOFT SHELLS FOR TESTING/ANALYSIS; HOWEVER, AS OF THE DATE OF THIS REPORT, THEY HAVE NOT BEEN RECEIVED. THE CUSTOMER APPEARS TO HAVE EXPERIENCED AN ALLERGIC REACTION TO THE SOFT SHELLS. SHOULD ADDITIONAL INFO OR THE PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.