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

Model Number	101041265
Health Effect - Clinical Code	Blister (4537)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying user was using correct kit components; verifying user was washing parts according to instructions for use; verified user was using dry parts when pumping; verified no milk backup occurred; verified correct breast shield fit.The troubleshooting did not resolve the issue.The customer stated she has not tried out her old breast shields on her pump in style maxflow pump.She indicated she has consulted with a lactation consultant in regards to her breast shield sizing.The customer was sent a replacement pump, pumping parts and breast shields and return of her original pump and parts was requested for testing/evaluation.In follow up with a complaint handler on 11/07/22, the customer indicated that she started having nipple blisters after 1 week of using her pump in style maxflow pump.She sought medical attention and was prescribed a compound antibiotic ointment, mupirocin to treat the blisters.She stated she is no longer having issues of pain with her older pump in style advanced pump, she has stopped using the pump in style maxflow.In further follow up with a complaint handler on 11/15/22, the customer indicated she tried out the replacement pump and accessories and it has not caused any nipple blisters.She prefers to pump with her old pump in style advanced pump versus the pump in style maxflow as it is more comfortable and effective for her.The device was returned with the customer's parts and accessories and was evaluated on 11/16/22.The customers connectors were damaged when they arrived.The device was tested with a lab kit and the customer's kit and the issue of no suction was not reproduced.
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc while using her pump in style maxflow she was having issues with the pump not having reliable suction.She also stated she had to increase the pumps suction so high to get proper milk expression that it caused blisters on her nipples.She also thought that the breast shields, connectors and membranes were causing productivity issues.She had to rely on her older pump in style advanced breast pump to get her through pumping, it is working well for her.

• Brand Name: PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 15806763
• Report Number: 1419937-2022-00089
• Device Sequence Number: 12112948
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/16/2022

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: 101041265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Distributor Facility Aware Date: 11/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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