MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE BREAST PUMP EN ES FR; PUMP, BREAST, POWERED

Model Number	101041361
Health Effect - Clinical Codes	Unspecified Infection (1930); Blister (4537)
Date of Event	08/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service responded via email with troubleshooting tips for the harmony breast pump (b)(6) 2022, and requested some additional information that was needed to resolve her issue.The customer responded via email with the additional information and the part she was requesting to be replaced.Customer service sent the customer a replacement part for her harmony breast pump.In follow up with a complaint handler on (b)(6) 2022, the customer stated that she developed mastitis approximately 6 weeks postpartum while using the pump in style max flow breast pump.Additionally she stated that she was prescribed cephalexin both times.The customer also indicated that since she switched to the harmony breast pump she has not had mastitis and the harmony is working well for her.The complaint handler encouraged her to contact customer service to resolve her issue with the pump in style max flow.Based on the results of our internal investigation (reference number 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 (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 of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2022, the customer alleged via email that she had the pump in style breast pump and she suffered from mastitis twice and had to be medicated.Additionally, she alleged that in order to heal from several bouts of nipple blisters, cracks and bleeding, she purchased a harmony manual breast pump, which was a life saver.The customer alleged that she needed assistance and guidance on the harmony pump and attached pictures of the of the upc and product number.

• Brand Name: PUMP IN STYLE BREAST PUMP EN ES FR
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 15459035
• Report Number: 1419937-2022-00076
• Device Sequence Number: 17643776
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 101041361
• Device Catalogue Number: 101041361
• Device Lot Number: 0000037569
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2022
• Initial Report FDA Received Date: 09/20/2022
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female