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

Model Number 57081

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

Patient Problem Occlusion (1984)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The customer was sent 21 mm breast shields and the 24 mm breast shields involved in the reported issue were requested for return.In follow up with a complaint handler on (b)(6) 2018, the customer alleged that she was diagnosed with mastitis, for which she was prescribed an antibiotic.She indicated that she was working on massaging out the clogged duct, as her breast was still sore and tender and that she has an appointment with a lactation consultant to come to some sort of resolution regarding the breast shield fit issue.She declined return of the 24 mm breast shields until her lactation consultant determines which size she should be using.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.Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is 0.008% for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." riordan and wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

On (b)(6) 2018, the customer reported to medela llc that she feels that the 24 mm breast shields which she was using with her pump in style breast pump are too large, as they are allowing too much of her areola into the tunnel and it hurts.She additionally alleged that she has blocked ducts.

Manufacturer Narrative

In follow up with a medela clinician on 02/19/2018, the customer described the circumstances when she had mastitis.The first was after her baby was born and she was not nursing effectively and the second was after she had slept at night and had not pumped as often as she usually did.She started exclusive pumping after 7 days of attempted nursing.She stated that she compresses her breasts and massages them very firmly throughout a 20 minute pumping session.The clinician discussed gentle compression with pumping and the specifics regarding exclusive pumping, with which the customer expressed understanding and compliance.The customer indicated that she wanted to try 27mm breast shields, which were sent to her.In follow up with the medela clinician again on 02/22/2018, the customer indicated that the 27mm breast shields were working well and she was not experiencing any pain or discomfort with pumping and they were emptying her breasts well.The customer indicated that she had no signs of mastitis.

• Brand Name: BREASTPUMP PNSA STARTER
• 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 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7286747
• MDR Text Key: 100614086
• Report Number: 1419937-2018-00052
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/15/2018
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other