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

Model Number 67186

Device Problem Decrease in Suction (1146)

Patient Problem No Code Available (3191)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump to help resolve her issue.In follow up with a medela clinician on (b)(6) 2017, the customer reported that she was diagnosed with mastitis and prescribed dicloxacillin by her doctor.In an additional follow up with a medela clinician on (b)(6) 2017, the customer stated that her mastitis is resolved and she has finished her antibiotic.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.It cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.Reported issues of mastitis are under investigation in ir14-(b)(4).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

The customer reported to customer service on (b)(6) 2017, that she was experiencing low suction with her harmony breast pump.

• 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: 6502917
• MDR Text Key: 73100533
• Report Number: 1419937-2017-00110
• Device Sequence Number: 1
• Product Code: HGY
• 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
• Report Date: 04/18/2017

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: 04/10/2017
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 04/19/2017
• 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