PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
Received Apr 9, 2014 · Event occurred Mar 10, 2014
Report 1419937-2014-00345 · MDR key 3760978
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Unspecified Infection
- Pain
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE 24MM BREASTSHIELDS WERE CAUSING HER PAIN. F/U WITH THE CUSTOMER CONFIRMED SHE HAD MASTITIS.
Additional Manufacturer Narrative
CUSTOMER SERVICE SENT REPLACEMENT BREASTSHIELDS TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, SHE STATED THAT SHE HAD MASTITIS. SHE ALSO INDICATED THAT HER BABY WAS HAVING TROUBLE LATCHING ONTO HER BREAST. SHE WAS DIAGNOSED AND TREATED FOR MASTITIS. SHE CONFIRMED THAT THE NEW BREAST SHIELDS WERE MUCH BETTER. 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." RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.