MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number 101041360

Device Problem Obstruction of Flow (2423)

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

Event Date 07/11/2021

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 07/21/2021, the customer indicated that she was actually hospitalized until (b)(6) 2021 due to the infection getting out of control.The customer stated that the mastitis started on (b)(6) 2021, and she was then hospitalized for three days and went home with antibiotics.On 7/29/2021, the customer stated that she went to the doctor on (b)(6) 2021, and the doctor indicated that the mastitis was looking good and he will be stopping the antibiotics.The customer indicated that she received her replacement pump and it seems to be working great.Based on the results of our internal investigation (b)(4), 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 of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However in this case, the mother's mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

On 07/16/2021, the customer alleged to medela llc that her pump in style max flow breast pump had a milk back up.She additionally alleged that she got an infection on her cracking nipples along with a breast infection due to having to pump often.

Manufacturer Narrative

The device was returned with the customer's tubing and was evaluated on 09/14/2021.The device did not "pass" suction and cycle specifications when tested with the customer tubing and lab connectors and membranes.Breast milk residue was found on the tubing, the breast pump motor aggregate (motor and pump assembly), housing, chassis, manifold, motor, solenoid and keypad.The customer's report of milk backup was confirmed.

• Brand Name: PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 12293194
• MDR Text Key: 265558779
• Report Number: 1419937-2021-00059
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (y/n): N
• PMA/PMN Number: K200508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101041360
• Device Catalogue Number: 101041360
• Device Lot Number: 0000022605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other