MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number	57081
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional breast shields and inserts were sent to the customer.In follow up with the customer, she stated that she was experiencing pain using the 24mm breast shields that came with the pump.She tried the 27mm because she thought she needed a larger size, but they caused even more pain.She switched to the 21mm breast shields and did not experience pain, but she wasn't expressing much milk, so she switched back to the 24mm.She stated that she was experiencing redness around the areola and was prescribed jack newman's nipple cream by her physician.She stated that she still has a little pain due to sensitivity issues.The instructions for use, item number 1(b)(4), rev e and page 20, 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) 2017, the customer reported to medela llc that she was experiencing pain when using the 21mm and 24mm breast shields for her pump in style advance breast pump.She also stated the she tried the 30mm breast shields and experienced no pain, but was not expressing much milk.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 6963495
• Report Number: 1419937-2017-00295
• Device Sequence Number: 1221883
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: (01)00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/19/2017

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: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Distributor Facility Aware Date: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/19/2017
• 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