MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 57063

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Injury (2348)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Because the customer indicated that her areola was going into the tunnel of the 24 mm breast shield, it was determined that the customer was using an incorrect breast shield size.The customer was sent 21 mm breast shields.In follow up with the customer on (b)(6) 2017, she stated that when using the 24 mm breast shields, she experienced bruising, blistering, and bleeding, for which she was prescribed an all purpose nipple ointment.She stated that she received the 21 mm breast shields and they resolved her fit issue and she was healing.Though the complaint information does not reasonably suggest that our device caused or contributed to the injury or the device malfunctioned, medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).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.

Event Description

On (b)(6) 2017, the customer alleged to medela llc that the 24 mm breast shields she was using with her pump in style breast pump may be the incorrect size, as they hurt her nipples and one nipple was cracked.

Manufacturer Narrative

The breast shields were received on 11/16/2017 and evaluated on 11/29/2017.The evaluation found no issues with the breast shields and, along with the fact that the 21mm breast shields resolved the customer's issue, confirmed that the customer's report was the result of a breast shield fit issue.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.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• 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: 7062894
• MDR Text Key: 93063125
• Report Number: 1419937-2017-00330
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/30/2017
• Date Manufacturer Received: 10/30/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other