MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-07 for SOFTSHELLS, INVERTED NIPPLES 80220 manufactured by Medela, Inc..
[17616179]
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.
Patient Sequence No: 1, Text Type: D, B5
[17715325]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2014-00161 |
| MDR Report Key | 3642032 |
| Report Source | 04 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-15 |
| Date of Event | 2014-01-15 |
| Date Facility Aware | 2014-01-15 |
| Report Date | 2014-01-15 |
| Date Mfgr Received | 2014-01-15 |
| Date Added to Maude | 2014-02-25 |
| 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 | DON ALEXANDER |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTSHELLS, INVERTED NIPPLES |
| Product Code | HFS |
| Date Received | 2014-02-07 |
| Model Number | 80220 |
| Catalog Number | 80220 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA, INC. |
| Manufacturer Address | MCHENRY IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |