SOFTSHELLS, INVERTED NIPPLES
Received Feb 7, 2014 · Event occurred Jan 15, 2014
Report 1419937-2014-00161 · MDR key 3642032
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER NIPPLES WERE STAYING MOIST AND NOT ALLOWING FOR THEM TO DRY, WHILE USING THE SOFT SHELL INVERTED NIPPLE.
Additional Manufacturer Narrative
REPLACEMENT SOFTSHELL WERE SENT TO THE CUSTOMER. A MEDELA CLINICIAN FOLLOWED UP WITH THE CUSTOMER WHO FOUND SOFT SHELLS FOR INVERTED NIPPLES DID NOT MEET HER NEEDS BECAUSE MOISTURE WAS TRAPPED AND IRRITATION INCREASED. CUSTOMER STATES SHE RECEIVED MEDICAL ATTENTION FROM DERMATOLOGIST WHO DIAGNOSED THRUSH AND TREATED BOTH MOTHER AND BABY; BOTH ARE NOT RECOVERED AND ISSUE IS RESOLVED. 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 OT THE EVENT. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE SOFTSHELL CAUSED OR CONTRIBUTED TO THE CUSTOMERS THRUSH. REPORTED ISSUES WITH THRUSH ARE UNDER INVESTIGATION (B)(4). SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECT INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. SEE SCANNED PAGE.