MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number	101036453
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service verified correct breast shield fit with the customer and sent out 27mm and 30mm breast shields for customer to try.In follow up with a complaint handler on 03/25/2021, the customer indicated she was still experiencing sores with the new larger sized breast shields and was having trouble expressing with the pump in style breast pump.The case was assigned to a medela clinician for follow up, who emailed the customer and after obtaining proof of purchase arranged for a replacement pump to be sent.Return of her original pump was requested for testing/evaluation.Subsequently on (b)(6) 2021, the clinician was able to speak with the customer by phone and she indicated the replacement pump was working well for her and her nipple sores were healing after using prescribed apno cream and coconut oil.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2021 the customer alleged to medela llc that her pump in style breast pump was causing pain and she had sores at the base of her nipples.She additionally alleged that she had already tried smaller breast shields and her doctor had confirmed the pain was caused by the pump and not the baby.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 11821405
• Report Number: 1419937-2021-00038
• Device Sequence Number: 1061123
• Product Code: HGX
• UDI-Device Identifier: 00020451364537
• UDI-Public: 020451364537
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K181937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 101036453
• Device Catalogue Number: 101036453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1