MAUDE MDR 4713506

MDR report key
4713506
Report number
3006774448-2015-00001
Event key
0
Event type
3
Date of event
2015-03-18
Date received
2015-04-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOHN GHERMAN
Address
6005 HIDDEN VALLEY ROAD SUITE 230 CARLSBAD CA 92011 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYGEIA FLANGEFLANGEHYGEIA II MEDICAL GROUP, INC.HGYNANANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-1701. O

Event Narratives#

D

Patient 1

THE CUSTOMER CONTACTED OUR CUSTOMER SERVICE REPRESENTATIVE ON (B)(6) 2015 STATING THAT THE CUSTOMER BELIEVES THAT THE CUSTOMERS FLANGES WERE NOT THE RIGHT SIDE. THE CUSTOMER STATED THAT THE CUSTOMERS NIPPLES HAVE BEEN STARTED BLEEDING AND NOT BECAUSE OF THE NIPPLES BEING CHAPPED, BUT BY THE NIPPLES GETTING CUT BY THE FLANGE. INSIDE THE FLANGE, THERE IS A HALF MOON SHAPE THAT ALLOWS THE MILK TO DRAIN INTO THE FLANGE CHAMBER AND THEN INTO THE COLLECTION CONTAINER. THE CUSTOMER STATED THAT THE CUSTOMER BELIEVES THIS IS WHERE THE CUTS WERE OCCURRING. THE FIRST TIME IT OCCURRED WAS ABOUT 6 WEEKS PRIOR TO THE CUSTOMERS (B)(6) 2015 PHONE CALL, AND THEN AGAIN ON (B)(6) 2015 WHEN THE CUSTOMER CONTACTED OUR CUSTOMER SERVICE REPRESENTATIVE. THE CUSTOMER WAS USING A MEDIUM SIZE FLANGE.

N

Patient 1

MARKETING MATERIAL INCLUDES INSTRUCTIONS ON WHAT SIZE FLANGE CUSTOMERS TO USE. THERE IS A VIDEO THAT EXPLAINS THE FLANGE SIZE SELECTION OF HYGEIA'S (B)(6) CHANNEL, AS WELL AS UNDER THE FAQ SECTION OF THE HYGEIA WEBSITE. PROPERLY FITTING FLANGES ARE IMPORTANT FOR BOTH COMFORT AND EFFICIENT BREAST PUMPING. WHILE BREAST PUMPING, YOUR NIPPLE SHOULD MOVE FREELY IN AND OUT OF THE FLANGE TUNNEL, AND THERE SHOULD BE NO RUBBING OR STICKING ON THE SIDES OR BACK OF THE FLANGE. IF A CUSTOMER SHOULD FEEL ANY DISCOMFORT OR PAIN WHILE BREAST PUMPING, IT IS OFTEN A SIGN THAT YOU NEED A LARGER FLANGE. NIPPLE BLANCHING AT THE BASE OF THE NIPPLE WHILE BREAST PUMPING IS ANOTHER INDICATOR THAT THE FLANGE MAY BE TOO SMALL. FLANGE SIZES ARE NOT RELATED TO THE CUSTOMER'S BREAST SIZE, BUT RATHER THE SIZE OF THE CUSTOMER'S NIPPLE. INVESTIGATION WAS FOUND THAT THE CUSTOMER HAD ORDERED THE INCORRECT SIZE FLANGE. OUR CUSTOMER SERVICE REPRESENTATIVE SENT THE CUSTOMER SIZE LARGE FLANGES. CUSTOMER SERVICE FOLLOWED-UP WITH THE CUSTOMER, AND BY USING SIZE LARGE FLANGES RESOLVED THE ISSUE.