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

Model Number 67186

Device Problem Decrease in Suction (1146)

Patient Problem Unspecified Infection (1930)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

Customer service provided the customer with troubleshooting tips via email.In follow up email correspondence between the customer and a complaint handler, the customer provided additional information, stating that she was diagnosed with mastitis by her obgyn on (b)(6) 2017, while using both the harmony and freestyle pumps, and was prescribed an antibiotic, which she is currently taking, though she is no longer experiencing any mastitis-related issues.She alleged that the harmony pump started to lose its suction and she felt like the silicone piece that attaches the valve to the handle was not as tight as it was when she first purchased it, which she believed might have been causing the suction issues.She indicated that she has been very thorough in cleaning every part of the pump after every use and that she conducted the troubleshooting recommended by customer service, but it did not resolve her issue.The customer indicated that there was no failure of the freestyle pump, she just preferred the harmony because she felt that her breasts responded a little better to it.The complaint handler recommended that the customer phone into customer service to address the suction issues with the harmony.Because the customer was using both the harmony and the freestyle when she was diagnosed with mastitis, two medwatches are being filed; this medwatch for the harmony and 1419937-2017-00187 for the freestyle.Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.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 06/21/2017, the customer emailed to customer service that she bought a freestyle breast pump and other medela products, all of which worked very well.However, after she got mastitis twice, she decided to purchase a more portable pump and bought a harmony, which she liked even better than the freestyle.However, she alleged that after only one month of using it, the suction depleted significantly, and she cannot get a "good pump out of it.".

• Brand Name: HARMONY MANUAL BREASTPUMP
• 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 drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6686299
• MDR Text Key: 79058723
• Report Number: 1419937-2017-00186
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Distributor Facility Aware Date: 06/23/2017
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other