MAUDE Adverse Event Report: MEDELA LLC HARMONY MANUAL BREAST PUMP WITH PF FLEX EN FR ES; PUMP, BREAST, NON-POWERED

Model Number 101041149

Device Problem Suction Failure (4039)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 09/09/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the customer alleged to medela llc that she had no suction with her harmony breast pump and now has mastitis because she couldn't pump.

Manufacturer Narrative

Customer service determined during troubleshooting that the customer was missing the o-ring on her harmony breast pump which was producing no suction.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with the complaint handler on 9/21/2021, the customer stated that she was diagnosed with mastitis on (b)(6) 2021 and was prescribed an antibiotic.In follow up again with the customer on (b)(6) 2021, the customer indicated that her new pump works way better than her old one did.The customer also indicated that the mastitis is resolved and she feels complete relief.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.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 BREAST PUMP WITH PF FLEX EN FR ES
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 12631834
• MDR Text Key: 281084975
• Report Number: 1419937-2021-00096
• Device Sequence Number: 1
• Product Code: HGY
• UDI-Device Identifier: 00020451411491
• UDI-Public: 020451411491
• Combination Product (y/n): N
• PMA/PMN Number: K823840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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: 101041149
• Device Catalogue Number: 101041149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other