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

Model Number	57081
Health Effect - Clinical Codes	Urticaria (2278); Reaction (2414)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service requested the 24 mm personal fit breast shields be returned for testing / evaluation, but the customer refused.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).Reported issues of rash were investigated under in (b)(4), which determined the root cause to be potential for the product, after it is opened, to come in contact with environmental allergens, lotions or creams, and cleaning solutions that may cause an allergic reaction or irritation.Such root cause is not a product malfunction or a deficiency in information available to the user.
Event or Problem Description
On (b)(6) 2019, the customer alleged to medela llc that she had an allergic reaction to the personal fit 24 mm breast shields she was using with her pump in style breast pump.She additionally alleged that she had hives and had seen a doctor, who prescribed her a steroid medication.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 9320774
• Report Number: 1419937-2019-00146
• Device Sequence Number: 13550061
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 10/23/2019
• Initial Report FDA Received Date: 11/14/2019
• 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