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

Model Number	57081
Health Effect - Clinical Codes	Erythema (1840); Irritation (1941); Pain (1994)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer indicated that according to the medela breast shield sizing chart, she needs a 30mm breast shield.The customer was sent 30mm breast shields and return of the 24mm breast shields were requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2018, the customer indicated that the redness and itchiness had spread all over her breast and was painful and itchy at night and that her doctor prescribed medication, which required her to stop breastfeeding; though the medication did not help much.The customer indicated that though she hadn't been pumping much, the 30mm breast shields fit much better and she anticipated using them more, once her skin condition improved.In follow up with a complaint handler on (b)(6) 2018, in response to an inquiry about the possibility of an allergic reaction to the breast shields, the customer indicated that her doctor gave her no such indication.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.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 (b)(4) that the 24mm breast shields she was using with her pump in style breast pump were too small.The customer alleged that she was having redness, pain and irritation on her nipple when pumping, that it seemed as if the breast shield was scratching her.
Additional Manufacturer Narrative
The breast shields were evaluated and passed a visual inspection and met product specifications; no issues were identified.

• 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: 7610488
• Report Number: 1419937-2018-00147
• Device Sequence Number: 134530
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/18/2018

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
• Device Lot Number: 10444309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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