MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problems Crack (1135); Increase in Suction (1604)

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

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

Customer service verified the breast shield fit with the customer and determined that her breast shields were the incorrect size.A replacement pump and smaller breastshields were set to the customer.The customer contacted a complaint handler on 08/10/2017 to clarify that she was diagnosed with mastitis one time, not multiple times, and that she was not certain that it was caused from the pump as she was pumping only once in a while.She was diagnosed on (b)(6) 2017, was prescribed an antibiotic and took it for four days at the time.She is no longer taking the antibiotics, is no longer experiencing any signs/symptoms of mastitis, and her issue has been resolved.Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.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) 2017, the customer alleged that the suction on her pump in style breast pump was high suction, the tubing was cracked and the breast shields were too big.The customer alleged that she has not been able to empty her breasts and she has had mastitis and clogged ducts a couple of times.

• Brand Name: BREASTPUMP PNSA STARTER
• 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 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6823474
• MDR Text Key: 83775686
• Report Number: 1419937-2017-00239
• 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: 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2017
• Date Manufacturer Received: 08/10/2017
• 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