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

Model Number 67186

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

On 02/24/2021, customer service responded to the customer via email to contact medela by either phone or chat to better address the issue.On (b)(6) 2021, the customer contacted medela llc and alleged that she developed mastitis a couple of times and had gone to the doctor.She also indicated that she had two harmony breast pumps.Two replacement diaphragm assemblies were sent to the customer and the return of her original was requested for testing/evaluation.On (b)(6) 2021, the customer emailed indicating that she received the wrong item.On (b)(6) 2021, the customer called medela llc and indicated that she received the wrong item and two replacement diaphragm assemblies were sent to the customer.In follow up with a complaint handler on (b)(6) 2021, the customer indicated that she received the replacement diaphragm and was asking if she could also be sent the diaphragm stem with oring.On (b)(6) 2021, the complaint handler advised the customer to contact medela customer service and the customer responded that she would contact customer service.On (b)(6) 2021, the customer called and left a voicemail for the complaint handler stating that she would like the additional part sent.Again, the customer was advised to contact medela customer service.On (b)(6) 2021, the complaint handler contacted the customer to see if the replacement parts were received and if her mastitis was resolved along with the status of returning the original harmony parts.The customer responded that she received the parts.Based on the results of our internal investigation (reference number (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 of 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) 2021, the customer alleged via email to medela llc that her harmony breast pump had a tiny hole in the plastic part where you pump milk and the air is expelling preventing the milk from being expressed.

• Brand Name: HARMONY MANUAL BREASTPUMP
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry, il
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 11556021
• MDR Text Key: 243128389
• Report Number: 1419937-2021-00023
• 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

• 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
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/23/2021
• 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