MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number 57062

Device Problem Increase in Suction (1604)

Patient Problem Unspecified Infection (1930)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.In follow up with a medela clinician on (b)(6) 2017, the customer stated that she was diagnosed with mastitis by her ob doctor and was treated with an antibiotic.The customer stated that her mastitis is resolved.The customer also stated that she is being treated for thrush though her doctor is not sure if she has it.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.It cannot be definitively concluded that the pump caused or contributed to the customer¿s thrush.Reported issues of thrush are under investigation in ir13-(b)(4).

Event Description

The customer reported to customer service that she was experiencing high suction with her pump in style advanced breast pump and it seem to be revving up on its own.The customer also reported that she had mastitis.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6537218
• MDR Text Key: 74198262
• Report Number: 1419937-2017-00130
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/24/2017
• Date Manufacturer Received: 04/24/2017
• 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