MAUDE Adverse Event Report: MEDELA LLC PNSA STARTER BP EN ES USA; PUMP, BREAST, POWERED

Model Number 101035077

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

The customer was sent replacement 21mm personal fit breast shields so that she could return them to a retail location for a refund and her original breast shields were requested to be returned for testing/evaluation.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 (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 Description

On (b)(6) 2020, the customer alleged to medela llc that the 21mm personal fit breast shields she was using with her pump in style breast pump had caused her to develop a rash.She additionally alleged that she had seen a dermatologist and her obgyn doctor, who advised her that it was an allergic reaction to polypropylene and she was prescribed a steroid as treatment for two weeks.

• Brand Name: PNSA STARTER BP EN ES USA
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 9639563
• MDR Text Key: 176751185
• Report Number: 1419937-2020-00005
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 00020451350776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101035077
• Device Catalogue Number: 101035077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other