MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for ADVANCED PERSONAL DOUBLE BREASTPUMP 101038299 manufactured by Medela Llc.
[177747250]
Customer service placed an order for a replacement diaphragm and assembly for her harmony pump. On (b)(6) 2019, the customer emailed the complaint handler indicating that she did not receive the replacement harmony parts, but instead received a faceplate to a pump in style breast pump. The complaint handler emailed customer service, asking that the harmony replacement parts be re-sent to the customer. In follow up with a complaint handler on (b)(6) 2020, the customer indicated that she developed mastitis on (b)(6) 2019 while using her pump in style breast pump, which was not emptying her completely. She was prescribed three different antibiotics, two of which failed. She rented a symphony pump from the hospital when she had mastitis because it emptied her more completely. She did see a physical therapist, who recommended that she use the harmony for occasional use when needed to relieve engorgement. She loves the harmony and finds it extremely helpful. She indicated that the mastitis was resolved. In further follow up with a complaint handler on (b)(6) 2020, the customer stated that she received the harmony replacement parts and the pump was working without issue. She manages her engorgement through occasionally pumping with the manual pump. 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 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
[177747251]
On (b)(6) 2020, the customer alleged to medela llc via email that she was unhappy with her harmony manual breast pump, as she had noticed a lack of suction and she was engorged. She indicated that she found that the o-ring was missing after troubleshooting on her own. She additionally alleged that she had been dealing with blocked ducts and recurrent mastitis, for which she was on antibiotics for one month, due to oversupply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00008 |
| MDR Report Key | 9664406 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Event | 2019-09-28 |
| Date Mfgr Received | 2020-01-05 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DR |
| 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 | ADVANCED PERSONAL DOUBLE BREASTPUMP |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-02-04 |
| Model Number | 101038299 |
| Catalog Number | 101038299 |
| Lot Number | 454129 |
| 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 DR MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |