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

Model Number	57081
Health Effect - Clinical Codes	Unspecified Infection (1930); Irritation (1941)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement pump was sent to the customer.In follow up with a medela lactation consultant on (b)(6) 2017, the customer indicated that she had mastitis around halloween.She also indicated that the replacement pump was working without issue.Based on the results of ca11-001, 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 0.008% 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 or mastitis." riordanand 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 or Problem Description
On (b)(6) 2017, the customer alleged to medela llc that the suction on her pump in style breast pump was too strong, even on the minimum setting, causing cracked and bloody nipples.She alleged that she went to her lactation consultant and they thought she had mastitis and was prescribed antibiotics.She alleged that she was sized for the 24 mm breast shields and did not have any nipple issues when using the symphony breast pump.
Additional Manufacturer Narrative
The device was returned with the customer's power supply and tubing and was evaluated on 02/05/2018 using a medela lab kit.The device passed all suction and cycle specifications.It was identified during the evaluation that the faceplate was damaged.Refer to attached evaluation.The customer's complaint of high suction could not be confirmed.[(b)(4)].

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 7125971
• Report Number: 1419937-2017-00352
• Device Sequence Number: 1331849
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: (01)00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K031614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Device Lot Number: 435445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Distributor Facility Aware Date: 11/20/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other