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

Model Number	57081
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In follow up with the customer related to her mastitis allegation with the swing pump, on (b)(6) 2018 she indicated that she experienced mastitis, which started on (b)(6) 2018, and then recurred on (b)(6) 2018, while using both the pump in style and swing breast pumps, as well as the replacement pump in style which was sent to her in response to her original report on (b)(6) 2018.She indicated that she was prescribed various courses of antibiotics and she just finished the last course and was hopeful that the mastitis would resolve.She also indicated that even after trying the swing pump with the power supply and new batteries, she continued to have issues, so a replacement swing pump was sent to the customer and return of her original swing pump was requested.In further follow up with the customer on (b)(6) 2018, she indicated that she was hospitalized for the mastitis and was being treated with iv antibiotics.In the hospital she was using a symphony breast pump and found that it was effective, so when she is released from the hospital, she is going to look into renting one.This medwatch report 1419937-2018-00101 relates to the original pump in style, medwatch report 1419937-2018-00102 relates to the swing and medwatch report 1419937-2018-00103 relates to the replacement pump in style.The original pump in style device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on (b)(6) 2018 and it passed suction and cycle specifications and did not generate a grinding noise, even though it was noted during the evaluation that there was damage to the retention snaps and the back plate mounting posts.Refer to attached evaluation.The customer's report of low suction related to the original pump in style could not be confirmed.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 (b)(6)%.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 (b)(6) 2013 to (b)(6) 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.(b)(4).
Event or Problem Description
On (b)(6) 2018, the customer alleged to medela llc via email that the pump in style breast pump which she received through her insurance, which she had been using for 5 weeks, was making a strange "grinding sound." she additionally alleged that she rarely double pumps with it because the suction "suffers." at this time, the customer made no mention of mastitis.Customer service emailed the customer troubleshooting tips, which helped her to identify an issue with the faceplate mounting posts, which she reported on (b)(6) 2018.At that time, the customer was sent a replacement device.On (b)(6) 2018, the same customer alleged to medela llc via email that she purchased a swing breast pump to use in addition to the pump in style and it was "terribly ineffective." she alleged that after using it for 10 days, the suction was negligible even at high levels and that she gets little milk compared to what she gets when using the pump in style.She further alleged that she had chronic mastitis.Customer service encouraged the customer to phone in so that her issue could be addressed.She phoned in on (b)(6) 2018 and indicated that she would test the pump using the power supply and also with new batteries.

• 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: 7422633
• Report Number: 1419937-2018-00101
• Device Sequence Number: 39292
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 0100020451570815
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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
• Device Lot Number: 44036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Distributor Facility Aware Date: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/11/2018
• 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