SOFTSHELLS - INVERTED NIPPLES

Additional Manufacturer Narrative

IN FOLLOW UP WITH A MEDELA CLINICIAN ON 08/16/2017 AND 08/19/2017, THE CUSTOMER STATED THAT THE MASS WAS NOT MASTITIS, AS EVIDENCED BY THE LAB RESULTS, BUT WAS INSTEAD A MILK-FILLED MASS THAT THE DOCTOR HAS DRAINED THREE TIMES. THE SURGEON FEELS IT IS JUST A BAD PLUGGED DUCT AND RECOMMENDED DRAINING IT AGAIN IF IT COMES BACK. THE CUSTOMER STATED THAT SHE FEELS BETTER, BUT THERE IS STILL A MASS WHICH IS RIGHT BENEATH WHERE THE SOFT SHELL FOR INVERTED NIPPLE SITS ON THE BREAST. SHE DOES NOT WEAR THE SOFT SHELLS ANYMORE. ON 08/28/2017, THE MEDELA CLINICIAN FOLLOWED ONCE AGAIN WITH THE CUSTOMER AND THE CUSTOMER INDICATED THAT SINCE THE MASS WAS LAST DRAINED, SHE HAS HAD NO FURTHER PROBLEMS, HAS NO PAIN AND A MASS IS NO LONGER PRESENT. THE INSTRUCTIONS FOR USE FOR THE SOFT SHELLS STATES: "ONLY WEAR THE BREAST SHELLS DURING WAKING HOURS" AND "WEAR BREAST SHELLS FOR A HALF HOUR BEFORE BREASTFEEDING. IF DISCOMFORT OCCURS WHILE WEARING THE SHELLS, DISCONTINUE USE."

Description of Event or Problem

ON (B)(6) 2017, THE CUSTOMER REPORTED VIA EMAIL THAT SHE USED THE SOFT SHELLS FOR INVERTED NIPPLES. SHE FOUND THAT THEY HELPED, SO SHE WORE THEM 24/7. SHE ALLEGED THAT SHE DEVELOPED A HUGE MASS IN HER BREAST. HER DOCTORS ARE NOT SURE WHAT IT IS, BUT THEY HAVE DONE AN ULTRASOUND AND ASPIRATED THE MASS AND NOW SAY THAT SHE NEEDS SURGERY.