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

Model Number 67186

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/11/2018

Event Type  Injury  

Manufacturer Narrative

Because the customer reported her issue through email, customer service sent troubleshooting tips via email and requested that she call in if the troubleshooting tips did not resolve the suction issue.In follow up with a complaint handler on (b)(6) 2018, the customer indicated that she developed mastitis the first time on (b)(6) 2018, while in the hospital but was not sure what brand pump she was using.She indicated that the second time she developed mastitis was (b)(6) 2018, while using the harmony breast pump, and was prescribed an antibiotic.She indicated that her mastitis has since resolved.Following contact with the customer, she was sent a replacement pump and return of her original pump was requested for testing/evaluation.Based on the results of (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 (b)(4)% 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) 2018, the customer alleged to medela (b)(4) via email that even after carefully cleaning her harmony manual breast pump as instructed, she has never been able to achieve any suction with the pump.The customer further alleged that she developed mastitis twice in the past and needs to be able to empty her breasts when away from the baby.

• 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: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7439518
• MDR Text Key: 105774584
• Report Number: 1419937-2018-00107
• 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: 04/18/2018

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: 04/11/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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