MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-18 for HARMONY MANUAL BREASTPUMP 67186 manufactured by Medela Llc.
[105774584]
Because the customer reported her issue through email, customer service sent troubleshooting tips via email and requested that she call in if the troubleshooting tips did not resolve the suction issue. In follow up with a complaint handler on (b)(6) 2018, the customer indicated that she developed mastitis the first time on (b)(6) 2018, while in the hospital but was not sure what brand pump she was using. She indicated that the second time she developed mastitis was (b)(6) 2018, while using the harmony breast pump, and was prescribed an antibiotic. She indicated that her mastitis has since resolved. Following contact with the customer, she was sent a replacement pump and return of her original pump was requested for testing/evaluation. 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
[105774585]
On (b)(6) 2018, the customer alleged to medela (b)(4) via email that even after carefully cleaning her harmony manual breast pump as instructed, she has never been able to achieve any suction with the pump. The customer further alleged that she developed mastitis twice in the past and needs to be able to empty her breasts when away from the baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2018-00107 |
| MDR Report Key | 7439518 |
| Report Source | CONSUMER |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-11 |
| Date Facility Aware | 2018-04-11 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-04-18 |
| 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 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 | HARMONY MANUAL BREASTPUMP |
| Generic Name | PUMP, BREAST, NON-POWERED |
| Product Code | HGY |
| Date Received | 2018-04-18 |
| Model Number | 67186 |
| Catalog Number | 67186 |
| 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 DR MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-18 |