PERSONAL FIT BREASTSHIELDS

Description of Event or Problem

THE CUSTOMER CALLED CUSTOMER SERVICE TO REPORT THAT SHE HAS DEVELOPED A REPEATED INFECTION IN HER BREASTS. HER DOCTOR BELIEVES THAT IT IS AN ALLERGY TO THE BREASTSHIELDS THAT ARE MANUFACTURED BY MEDELA.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT SHE HAD DEVELOPED AN INFECTION IN HER BREASTS. HER DOCTOR HAS PRESCRIBED ANTIBIOTICS FOR THE INFECTION. THE PRODUCT INVOLVED IN THE COMPLIANT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. A CLINICIAN FROM MEDELA IS GOING TO CONTACT THE CUSTOMER TO FOLLOW UP. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP WILL BE FILED THAT TIME. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OR MASTITIS." RIORDOAN & WAMBACH, 4TH ED. P.294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEVE AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.