MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-09 for PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK 101036453 manufactured by Medela Llc.
[182613844]
Customer service conducted troubleshooting with the customer, including inspecting the faceplate and back plate for damage; inspecting and cleaning the diaphragm; and the customer replaced all the pumping parts. Following troubleshooting, it was noted that one of the retention snaps on the faceplate was cracked. A replacement faceplate was sent to resolve the issue and return of the original faceplate was requested for testing. On (b)(6) 2020, the customer called back and alleged to medela llc that her pump in style breast pump was now not changing phases appropriately and would pause once going into letdown mode, then would not start unless suction was manually increased. Customer service again conducted troubleshooting by inspecting the faceplate and backplate for damage and the issue was not resolved. The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation. In follow up with a complaint handler between (b)(6) 2020, the customer indicated that she went to the doctor on (b)(6) 2020 and was prescribed an antibiotic and a shot, the replacement pump was working without issue, and the mastitis was resolved. 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 0. 008% 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
[182613845]
On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump works normally in the first phase, however, when switching into the second phase, it loses all the suction. She additionally alleged that she has mastitis, for which she has received antibiotics from her doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00021 |
| MDR Report Key | 9806690 |
| Report Source | CONSUMER |
| Date Received | 2020-03-09 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAN KLOIBER |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 4358316 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-03-09 |
| Model Number | 101036453 |
| Catalog Number | 101036453 |
| Lot Number | NA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |