MAUDE Adverse Event Report: MEDELA LLC HARMONY MANUAL PUMP 2.0 1CT EN FR ES; PUMP, BREAST, NON-POWERED

Model Number 101041149

Device Problem Suction Problem (2170)

Patient Problem Inflammation (1932)

Event Date 02/09/2024

Event Type  Injury  

Event Description

On 02/09/2024, the customer emailed medela llc and alleged that she was accumulating milk in her breast and that her breasts were throbbing and hurting.She developed a fever and was prescribed an antibiotic for mastitis.

Manufacturer Narrative

Customer was asked to contact customer service for additional assistance.In follow up with a complaint handler on 02/13/2024, the customer stated their pump was not fully functioning.They had been fitted for breast shields by a lactation consultant.They no longer have mastitis and is using a different brand breast pump.Based on the results of our internal investigation (reference number 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 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.

• Brand Name: HARMONY MANUAL PUMP 2.0 1CT EN FR ES
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 18697338
• MDR Text Key: 335296659
• Report Number: 1419937-2024-00004
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K823840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101041149
• Device Catalogue Number: 101041149
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2024
• Date Manufacturer Received: 02/09/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female