MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-20 for PUMP IN STYLE ADVANCED ON-THE-GO TOTE 101036449 manufactured by Medela Llc.
[176014406]
He customer was sent a replacement pump and return of her original pump was requested for testing/evaluation. The customer was contacted by a complaint handler on multiple occasions, including a fourth and final attempt in writing on (b)(6) 2019, to get additional information. In an emailed response to the complaint handler on (b)(6) 2019, the customer's husband indicated that his wife's mastitis resulted in a severe antibiotic reaction that put her in the hospital. He additionally indicated that the original pump had been returned and the delay was due to his son's medical issues, but the replacement pump was working flawlessly. He stated they were grateful for our patience, commitment to our products, and fantastic customer service. Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis. The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%. In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis. The complaint rate of mastitis across all reported failures, across all medela breast pumps, is 0. 008% for the period of (b)(6) 2013 to (b)(6) 2017. 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
[176014407]
On (b)(6) 2019, the customer alleged to medela llc that her pump in style breast pump had low suction and it does not empty her, though neither does her baby when she breastfeeds. She additionally alleged that she had mastitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00001 |
| MDR Report Key | 9606555 |
| Report Source | CONSUMER |
| Date Received | 2020-01-20 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2019-12-27 |
| Date Added to Maude | 2020-01-20 |
| 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 | JAN KLOIBER |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP IN STYLE ADVANCED ON-THE-GO TOTE |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-01-20 |
| Model Number | 101036449 |
| Catalog Number | 101036449 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DRIVE MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-20 |