MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-08 for SOFTSHELLS - INVERTED NIPPLES 80220 manufactured by Medela Ag.
[85276171]
In follow up with a medela clinician on 08/16/2017 and 08/19/2017, the customer stated that the mass was not mastitis, as evidenced by the lab results, but was instead a milk-filled mass that the doctor has drained three times. The surgeon feels it is just a bad plugged duct and recommended draining it again if it comes back. The customer stated that she feels better, but there is still a mass which is right beneath where the soft shell for inverted nipple sits on the breast. She does not wear the soft shells anymore. On 08/28/2017, the medela clinician followed once again with the customer and the customer indicated that since the mass was last drained, she has had no further problems, has no pain and a mass is no longer present. The instructions for use for the soft shells states: "only wear the breast shells during waking hours" and "wear breast shells for a half hour before breastfeeding. If discomfort occurs while wearing the shells, discontinue use. "
Patient Sequence No: 1, Text Type: N, H10
[85276172]
On (b)(6) 2017, the customer reported via email that she used the soft shells for inverted nipples. She found that they helped, so she wore them 24/7. She alleged that she developed a huge mass in her breast. Her doctors are not sure what it is, but they have done an ultrasound and aspirated the mass and now say that she needs surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2017-00258 |
| MDR Report Key | 6851135 |
| Report Source | CONSUMER |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-08-10 |
| Date Facility Aware | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| Date Added to Maude | 2017-09-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT SOKOLOWSKI |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | MEDELA AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR ZUG 6341 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTSHELLS - INVERTED NIPPLES |
| Generic Name | SHIELD, NIPPLE |
| Product Code | HFS |
| Date Received | 2017-09-08 |
| Model Number | 80220 |
| Catalog Number | 80220 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | BAAR ZUG,6341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-08 |