MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-09 for PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE 8107084-57063 8107084/57063 manufactured by Medela, Inc..
[4465028]
The customer reported to customer service that the 24mm breastshields were causing her pain. F/u with the customer confirmed she had mastitis.
Patient Sequence No: 1, Text Type: D, B5
[11866918]
Customer service sent replacement breastshields to the customer. In f/u with the customer, she stated that she had mastitis. She also indicated that her baby was having trouble latching onto her breast. She was diagnosed and treated for mastitis. She confirmed that the new breast shields were much better. It cannot be definitively concluded that the pump 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 to avoid progression to overwhelming sepsis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2014-00345 |
| MDR Report Key | 3760978 |
| Report Source | 04 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-03-10 |
| Date Facility Aware | 2014-03-10 |
| Report Date | 2014-03-10 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-04-22 |
| 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 | 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 | PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE |
| Product Code | HFS |
| Date Received | 2014-04-09 |
| Model Number | 8107084-57063 |
| Catalog Number | 8107084/57063 |
| Lot Number | UNK |
| 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 | MCHENRY IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-09 |