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

Model Number	57081
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because the customer made the report via email, customer service responded with an email requesting that she call in so that her issue could appropriately be addressed.In follow up with a complaint handler on 12/13/2018, the customer responded that she went to her lactation consultant who indicated that the pump was making an odd "knocking" noise when suctioning, which was not normal in her opinion.Additionally, the lactation consultant determined that she was using the correct size breast shield, but suggested that she also purchase a size down and recommended that she see her doctor to determine if she needs a prescription for her cracked and bleeding nipples.The customer indicated that she received a prescription nipple ointment from her doctor and the pain was minimal after using the prescription.The complaint handler asked the customer to contact customer service to troubleshoot her pump and address the issues she was having; however, as of the date of this report, the customer has not done so.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) 2018, the customer alleged to medela llc via email that she met with a lactation consultant who told her that her pump in style breast pump was defective, that the suction did not seem normal and it has been causing her some nipple damage.She additionally alleged that all of the parts and accessories were working properly.

• 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: 8235411
• Report Number: 1419937-2019-00008
• Device Sequence Number: 1582260
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• 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: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/10/2019
• 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