PERSONALL FIT BREAST SHIELDS
Received Aug 6, 2013 · Event occurred Jul 4, 2013
Report 1419937-2013-00386 · MDR key 3291995
Device
Product problems
- Fitting Problem
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO CUSTOMER SVC THAT THE SIZE 24 MM BREAST SHIELDS SEEMED NOT TO FIT CORRECTLY CAUSING PAIN WHICH REDUCED MILK SUPPLY CAUSING MASTITIS.
Additional Manufacturer Narrative
IN FOLLOW UP WITH THE CUSTOMER ON (B)(4) 2013 WITH A MEDELA CLINICIAN, THE CUSTOMER INFORMED THE CLINICIAN THAT EARLIER SHE HAD EXPERIENCED MASTITIS WHEN USING THE BREAST SHIELDS AND HER DOCTOR TEATED HER WITH ANTIBIOTICS. SHE RESPONDED WELL AND IS NOW RECOVERED. MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMOUNT WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS." RIORDAN & WAMBACH, 4TH ED. P. 294. 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). THE ORIGINAL PRODUCT WILL NOT BE RETURNED, NO PHYSICAL EVALUATION WILL BE COMPLETED.