MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-07-05 for HARMONY MANUAL BREASTPUMP 67186 manufactured by Medela Llc.
[79058723]
Customer service provided the customer with troubleshooting tips via email. In follow up email correspondence between the customer and a complaint handler, the customer provided additional information, stating that she was diagnosed with mastitis by her obgyn on (b)(6) 2017, while using both the harmony and freestyle pumps, and was prescribed an antibiotic, which she is currently taking, though she is no longer experiencing any mastitis-related issues. She alleged that the harmony pump started to lose its suction and she felt like the silicone piece that attaches the valve to the handle was not as tight as it was when she first purchased it, which she believed might have been causing the suction issues. She indicated that she has been very thorough in cleaning every part of the pump after every use and that she conducted the troubleshooting recommended by customer service, but it did not resolve her issue. The customer indicated that there was no failure of the freestyle pump, she just preferred the harmony because she felt that her breasts responded a little better to it. The complaint handler recommended that the customer phone into customer service to address the suction issues with the harmony. Because the customer was using both the harmony and the freestyle when she was diagnosed with mastitis, two medwatches are being filed; this medwatch for the harmony and 1419937-2017-00187 for the freestyle. Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer? S mastitis. 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 and 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
[79058724]
On 06/21/2017, the customer emailed to customer service that she bought a freestyle breast pump and other medela products, all of which worked very well. However, after she got mastitis twice, she decided to purchase a more portable pump and bought a harmony, which she liked even better than the freestyle. However, she alleged that after only one month of using it, the suction depleted significantly, and she cannot get a "good pump out of it. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2017-00186 |
| MDR Report Key | 6686299 |
| Report Source | CONSUMER |
| Date Received | 2017-07-05 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-06-20 |
| Date Facility Aware | 2017-06-23 |
| Date Mfgr Received | 2017-06-30 |
| Date Added to Maude | 2017-07-05 |
| 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 | ROBERT SOKOLOWSKI |
| 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 | 2017-07-05 |
| Model Number | 67186 |
| Catalog Number | 67186 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-07-05 |