MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE (UNKNOWN); PUMP, BREAST, POWERED

Model Number PUMP IN STYLE (UNKNOWN)

Device Problem Fitting Problem (2183)

Patient Problem Injury (2348)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Customer service requested that the customer phone in so that they could troubleshoot the issue with her.On (b)(6) 2018, in follow up with a complaint handler, the customer indicated that she was still experiencing a breast shield sizing issue, despite having consulted with a lactation specialist, and that she, in fact, had experienced broken skin and bleeding, for which she consulted a physician and was prescribed an all purpose nipple ointment.Because she was still having issues with breast shield sizing, the customer requested contact by a medela clinician.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 Description

On (b)(6) 2018, the customer reported to medela llc via email that she tried the 27 mm, 30 mm and 36 mm breast shields with her pump in style breast pump and alleged that she sustained nipple damage because she has long nipples and needs a funnel that is longer.

• Brand Name: PUMP IN STYLE (UNKNOWN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7189952
• MDR Text Key: 97342546
• Report Number: 1419937-2018-00014
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K150499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: PUMP IN STYLE (UNKNOWN)
• Device Catalogue Number: PUMP IN STYLE (UNKNOWN)
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/11/2018
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other