MAUDE Adverse Event Report: HYGEIA II MEDICAL GROUP, INC. HYGEIA FLANGE

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 03/18/2015

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: HYGEIA FLANGE
• Type of Device: FLANGE
• Manufacturer (Section D): HYGEIA II MEDICAL GROUP, INC.; 6005 hidden valley road; suite 230; carlsbad CA 92011
• Manufacturer Contact: john gherman ; 6005 hidden valley road; suite 230; carlsbad, CA 92011 ; 7145157571
• MDR Report Key: 4713506
• MDR Text Key: 18921201
• Report Number: 3006774448-2015-00001
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other