MAUDE Adverse Event Report: MEDELA LLC SONATA PUMP W/ FLEX SINGLE 1CT EN FR ES; PUMP, BREAST, POWERED

Model Number	101037319
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service sent the customer 30mm and 36mm breast shields to try and return of her original breast shields were requested for testing/analysis.In follow up with a complaint handler on (b)(6) 2020, the customer indicated she was using the 36mm breast shields.She further indicated that her doctor prescribed an antibiotic for the lump in her breast.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).The instructions for use provides instructions for breast shield sizing, including reference to medelabreastshields.Com and referral to a lactation consultant for assistance in choosing the correct size breast shield.
Event or Problem Description
On (b)(6) 2020, a dad alleged to medela llc that a lactation consultant told his daughter who was using the 21mm and 24mm flex breast shields with her sonata breast pump that they were too small.He additionally alleged that they caused a lump in her breast, for which his daughter was going to visit the doctor.

• Brand Name: SONATA PUMP W/ FLEX SINGLE 1CT EN FR ES
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 9947709
• Report Number: 1419937-2020-00035
• Device Sequence Number: 3257632
• Product Code: HGX
• UDI-Device Identifier: 00020451367507
• UDI-Public: 00020451367507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161725
• 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: 101037319
• Device Catalogue Number: 101037319
• Device Lot Number: 457326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/10/2020
• 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