MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-04-17 for HYGEIA FLANGE manufactured by Hygeia Ii Medical Group, Inc..
[18921201]
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.
Patient Sequence No: 1, Text Type: D, B5
[19065167]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006774448-2015-00001 |
| MDR Report Key | 4713506 |
| Report Source | 00 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-04-17 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-18 |
| Date Added to Maude | 2015-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GHERMAN |
| Manufacturer Street | 6005 HIDDEN VALLEY ROAD SUITE 230 |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7145157571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYGEIA FLANGE |
| Generic Name | FLANGE |
| Product Code | HGY |
| Date Received | 2015-04-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGEIA II MEDICAL GROUP, INC. |
| Manufacturer Address | 6005 HIDDEN VALLEY ROAD SUITE 230 CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-17 |