MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-26 for NIPPLE SHIELD 89907 manufactured by Medela Ag.
[115129987]
In follow up with a complaint handler on (b)(6) 2018, the customer confirmed that she developed mastitis around (b)(6) 2018 and was prescribed an antibiotic, but that at the time she was not using the pump in style breast pump, but was using medela nipple shields, due to a latch issue. The customer indicated that she has had two ultrasounds and still has mastitis with no drainable abscess, as the infection is broken up into multiple small areas that cannot be effectively drained. She continues to have a 4mm lump in her right breast, but is working with her doctor and a lactation nurse to resolve the issue. Follow up with medela clinical is ongoing. 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
[115129988]
On (b)(6) 2018, the customer alleged to medela (b)(4) via email that the suction on a borrowed pump in style breast pump was low due to excess air being pulled through the port on her faceplate. The customer also alleged that she had mastitis, for which she was prescribed an antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2018-00167 |
| MDR Report Key | 7723242 |
| Report Source | CONSUMER |
| Date Received | 2018-07-26 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-07-08 |
| Date Added to Maude | 2018-07-26 |
| 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 AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR ZUG 6341, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPPLE SHIELD |
| Generic Name | SHIELD, NIPPLE |
| Product Code | HFS |
| Date Received | 2018-07-26 |
| Model Number | 89907 |
| Catalog Number | 89907 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR ZUG 6341, SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-26 |