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 BREASTPUMP - BACKPACK 101036453 manufactured by Medela Llc.
[176015787]
Customer service conducted troubleshooting with the customer and the customer indicated that suction was restored. The customer was instructed to call back if the issue recurred. On (b)(6) 2019, the customer alleged that her pump in style breast pump had low suction again. The customer further alleged that she developed mastitis and was prescribed an antibiotic. Customer service asked the customer for proof of purchase to replace the pump. The customer indicated that she would call back and provide it. In follow up with a complaint handler on 01/07/2020, the customer indicated that she developed mastitis twice, but was not prescribed an antibiotic the first time. The customer indicated that the second time she developed mastitis was at the beginning of (b)(6) 2019, for which she had been prescribed an antibiotic. The customer stated the mastitis was resolved and that she had a second pump in style breast pump that she has been using since the mastitis. The customer indicated that she sent in a proof of purchase, but had not spoken to customer service. The complaint handler transferred the customer to customer service and a replacement device was sent to the customer. The customer was contacted again by a complaint handler on multiple occasions, including in writing, to follow up on the new pump and return of the old pump, with no additional response as of the date of this report. 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
[176015788]
On (b)(6) 2019, the customer alleged to medela llc that her pump in style breast pump had low suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00002 |
| MDR Report Key | 9606450 |
| Report Source | CONSUMER |
| Date Received | 2020-01-20 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-07-10 |
| 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 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 BREASTPUMP - BACKPACK |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-01-20 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 101036453 |
| Catalog Number | 101036453 |
| Lot Number | 455193 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DR MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |