MAUDE Adverse Event Report: MEDELA LLC HARMONY MANUAL BREASTPUMP; PUMP, BREAST, NON-POWERED

Model Number 67186

Device Problem Suction Problem (2170)

Patient Problem Inflammation (1932)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

The customer was emailed low suction troubleshooting tips and was asked to call in to customer service if this did not resolve her issue.In follow up with a complaint handler on 09/19/2020, the customer indicated that she developed mastitis on (b)(6) 2020 and was prescribed an antibiotic.She indicated that her mastitis was resolved, but she still had clogged ducts frequently.The customer was subsequently contacted by a complaint handler requesting she contact customer service for assistance in replacing her pump, but has not done so as of the date of this report.Based on the results of (b)(64), 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 & 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) 2020, the customer alleged to medela llc via email that her harmony manual pump, which she had been using for four months to help her relieve clogged ducts had low suction.She additionally alleged that she had mastitis a month ago and had checked her pump parts, cleaned, and reassembled them but was not able to resolve the issue.She indicated she had four other medela pumps, but used her manual pump often since she is an over producer who donates her milk and felt the manual pump was more powerful.

• Brand Name: HARMONY MANUAL BREASTPUMP
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry, il
• Manufacturer Contact: mike mcandrew ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 10678846
• MDR Text Key: 211357003
• Report Number: 1419937-2020-00115
• Device Sequence Number: 1
• Product Code: HGY
• UDI-Device Identifier: 00020451671864
• UDI-Public: 020451671864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823840
• 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: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67186
• Device Catalogue Number: 67186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other