MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ORIGINAL BREAST PUMP; PUMP, BREAST, POWERED

Model Number 57040

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

During troubleshooting, the customer indicated that the suction on the pump was strong and she believed that she was using the correct breast shield size.She stated that sometimes she needs to pump for an hour, though her milk is flowing and the pump is expressing.The customer was sent replacement personal fit flex breast shields and her original shields were requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2019, the customer confirmed that she developed mastitis for the first time in august and was treated with antibiotics on two occasions.She stated that she saw a lactation consultant and was fitted for the correct breast shield size.She indicated that the replacement shields were working without issue and the mastitis was resolved.The breast shields were evaluated on 11/20/2019 and it was noted that they had residue on them.Instructions for use details cleaning procedure for the parts and accessories.It is also a common troubleshooting item to check.Regardless, the customer's report did not include an allegation against the product, but that she developed mastitis while using it.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 (b)(6) 2013 to (b)(6) 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 & 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) 2019, the customer alleged to medela llc that she had mastitis four (4) times and was getting blisters on her nipples from pumping with her pump in style breast pump, though she indicated that the suction on the pump was good.She further alleged that she was treated by a doctor and was prescribed antibiotics, which she was taking as of the date of her report.

• Brand Name: PUMP IN STYLE ORIGINAL BREAST PUMP
• 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: 9363709
• MDR Text Key: 167767099
• Report Number: 1419937-2019-00152
• Device Sequence Number: 1
• Product Code: HGX
• 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: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57040
• Device Catalogue Number: 57040
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other