MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for PUMP IN STYLE ADVANCED ON-THE-GO TOTE 101036449 manufactured by Medela Llc.
[177677513]
Customer service conducted troubleshooting with the customer, including inspecting the faceplate and back plate for damage; inspecting and cleaning the diaphragm; disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit. Following troubleshooting, the customer indicated the troubleshooting did not resolve the issue. The 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 in writing, to get additional information, with no response as of the date of this report. Based on the results of (b)(4), 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 (b)(4)% for the period of january 2013 to august 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
[177677554]
On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump had low suction. She additionally alleged that she developed mastitis four (4) times, had taken antibiotics for the first two (2) occurrences, but for the last two occurrences she did not go to the doctor and the mastitis went away on its own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00004 |
| MDR Report Key | 9626838 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| 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 | 2020-01-24 |
| Model Number | 101036449 |
| Catalog Number | 101036449 |
| Lot Number | 453990 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2020-01-24 |