MAUDE Adverse Event Report: MEDELA LLC ADVANCED PERSONAL DOUBLE BREASTPUMP; PUMP, BREAST, POWERED

Model Number	101038299
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091)
Date of Event	09/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service placed an order for a replacement diaphragm and assembly for her harmony pump.On (b)(6) 2019, the customer emailed the complaint handler indicating that she did not receive the replacement harmony parts, but instead received a faceplate to a pump in style breast pump.The complaint handler emailed customer service, asking that the harmony replacement parts be re-sent to the customer.In follow up with a complaint handler on (b)(6) 2020, the customer indicated that she developed mastitis on (b)(6) 2019 while using her pump in style breast pump, which was not emptying her completely.She was prescribed three different antibiotics, two of which failed.She rented a symphony pump from the hospital when she had mastitis because it emptied her more completely.She did see a physical therapist, who recommended that she use the harmony for occasional use when needed to relieve engorgement.She loves the harmony and finds it extremely helpful.She indicated that the mastitis was resolved.In further follow up with a complaint handler on (b)(6) 2020, the customer stated that she received the harmony replacement parts and the pump was working without issue.She manages her engorgement through occasionally pumping with the manual pump.Based on the results of 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 0.008% 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) 2020, the customer alleged to medela llc via email that she was unhappy with her harmony manual breast pump, as she had noticed a lack of suction and she was engorged.She indicated that she found that the o-ring was missing after troubleshooting on her own.She additionally alleged that she had been dealing with blocked ducts and recurrent mastitis, for which she was on antibiotics for one month, due to oversupply.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 9664406
• Report Number: 1419937-2020-00008
• Device Sequence Number: 14145174
• Product Code: HGX
• UDI-Device Identifier: 00020451382999
• UDI-Public: 020451382999
• 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: 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: 101038299
• Device Catalogue Number: 101038299
• Device Lot Number: 454129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2020
• Initial Report FDA Received Date: 02/04/2020
• 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