MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number	57081
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service sent the customer troubleshooting tips via email, including tips for inspecting the faceplate and back plate for damage, inspecting and cleaning the diaphragm, disassembling, inspecting, cleaning and reassembling the kit and tubing set, and verifying breast shield fit.Additionally, the customer was asked to contact customer service via phone so that her issue could appropriately be addressed.In follow up with a complaint handler on 01/15/2019, the customer indicated that she developed mastitis on (b)(6) 2018 and was prescribed an antibiotic.She indicated that her pump started working again before she had a chance to contact customer service.She also indicated that the mastitis was resolved.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.
Event or Problem Description
On (b)(6) 2018 the customer alleged to medela llc via email that her pump in style breast pump started making a "cricket" sound and that she now has to set the vacuum level at the highest setting to express any milk, when previously she could use it on the lowest setting.She additionally alleged that she has replaced the parts and conducted recommended troubleshooting, without any improvement, and now has clogged ducts because she is unable to fully empty her breasts.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 8270126
• Report Number: 1419937-2019-00014
• Device Sequence Number: 2081292
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other