MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-21 for WILLOW WEARABLE BREAST PUMP PDW29 manufactured by Exploramed Nc7, Inc..
[176957663]
The customer reported mastitis which was treated by doctor prescribed iv antibiotics. The willow device has not yet been returned to exploramed nc7 for evaluation. However, a manufacturing review was conducted on the device history record and no nonconformances were noted in the production of this device. Based on the information provided, it cannot be definitively concluded that the willow breast pump caused or contributed to the incident of mastitis. Mastitis is usually a benign, self-limiting condition, with few consequences to the infant and incidence ranging from 4-27%. [1] a primary cause of mastitis is milk stasis within the breast, providing a medium for bacterial growth. [2,3,4] there are a variety of risk factors for mastitis, including missed or restricted feedings, breast engorgement, restriction from tight bra/ clothing, prone sleeping position, maternal stress, excessive fatigue, and malnutrition. [2,3,4,5]. Wambach, karen, and jan riordan. Breastfeeding and human lactation. 5th ed. , jones & bartlett learning, 2016. World health organization, mastitis causes & management, 2002. Spencer jp, management of mastitis in breastfeeding women, american family physician. 2008; 78 (6): 727-732. Michie c, the challenge of mastitis. Arch dis child. 2003: 88, 818-821. Foxman b, lactation mastitis: occurrence and medical management among 946 breastfeeding women in the united states. Am j epidemiol, 155 (2) 2002.
Patient Sequence No: 1, Text Type: N, H10
[176957664]
The customer reported to willow customer care on (b)(6) 2019 that she was treated for mastitis. She was treated by her physician with intravenous antibiotics. The customer had been using willow for at least 3 days prior to the condition developing and continued to use willow for several days afterward. She continued pumping with an alternate pump throughout treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012759464-2020-00001 |
| MDR Report Key | 9614298 |
| Report Source | CONSUMER |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-26 |
| Device Manufacturer Date | 2019-10-11 |
| Date Added to Maude | 2020-01-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN CHANG |
| Manufacturer Street | 1975 W. EL CAMINO REAL SUITE 306 |
| Manufacturer City | MOUNTAIN VIEW CA 94040 |
| Manufacturer Country | US |
| Manufacturer Postal | 94040 |
| Manufacturer Phone | 6505753465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLOW WEARABLE BREAST PUMP |
| Generic Name | POWERED BREAST PUMP, PRODUCT CODE |
| Product Code | HGX |
| Date Received | 2020-01-21 |
| Model Number | PDW29 |
| Catalog Number | PDW29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXPLORAMED NC7, INC. |
| Manufacturer Address | 1975 W. EL CAMINO REAL SUITE 306 MOUNTAIN VIEW CA 94040 US 94040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-21 |