PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDS
Received Jul 14, 2014 · Event occurred May 2, 2014
Report 1419937-2014-00553 · MDR key 3950973
Device
Manufacturer
Medela, Inc.Model number
8107175/87075/57063Catalog number
8107175/87075/57063
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT SHE HAS A RASH ON HER AREOLA THAT WAS INFECTED. HER DOCTOR PUT HER ON MYSTATIN OINTMENT, NEOSPRIN, HYDROCORTISONE CREAM 1%, DESONIDE OINTMENT 0.5%, CEPHALEXIN 50 MG 3X DAILY. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THIS ISSUE IS CURRENTLY BEING INVESTIGATED (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE BREASTSHIELDS SHE WAS USING WITH HER PUMP IN STYLE BREAST PUMP HAD CAUSED AN ALLERGIC REACTION THAT REQUIRED MEDICAL ATTENTION.