MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-31 for FREESTYLE HANDS FREE/BREASTSHIELD CONNECTORS 67060/8007226 manufactured by Medela, Inc..
[4323456]
Customer reported to customer service that she has mastitis and clogged ducts and will be seeing the doctor.
Patient Sequence No: 1, Text Type: D, B5
[11821272]
Replacement breastshield connectors have been sent the customer. Customer reported having mastitis. The product involved in the complaint was not returned for eval/investigation at this time. Therefore, no conclusions can be made as to the cause of the event. Should add'l info or the original product be received, resulting in new, changed, or corrected info, a follow up report will be filed at that time. It cannot be definitively concluded that the breastshield connectors caused or contributed to the customer's mastitis. Reported issues of mastitis are under investigation in (b)(4). Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant. The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis. " riordan & wambach, 4th ed. P. 294: breastfeeding and human lactation. Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2014-00319 |
| MDR Report Key | 3733534 |
| Report Source | 04 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-03-20 |
| Date of Event | 2014-03-19 |
| Date Facility Aware | 2014-03-20 |
| Report Date | 2014-03-20 |
| Date Mfgr Received | 2014-03-20 |
| Date Added to Maude | 2014-04-09 |
| 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 600507005 |
| Manufacturer Country | US |
| Manufacturer Postal | 600507005 |
| Manufacturer Phone | 8004358316 |
| Manufacturer G1 | MEDELA, INC. |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050700 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 7005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE HANDS FREE/BREASTSHIELD CONNECTORS |
| Product Code | HFS |
| Date Received | 2014-03-31 |
| Model Number | 67060/8007226 |
| Catalog Number | 67060/8007226 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA, INC. |
| Manufacturer Address | 1101 CORPORATE DR. MCHENRY IL 60050700 US 60050 7005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-31 |