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U.S. Department of Health and Human Services

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

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MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED Back to Search Results
Model Number 57081
Device Problems Decrease in Suction (1146); Suction Problem (2170)
Patient Problem Injury (2348)
Event Date 12/14/2017
Event Type  Injury  
Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including inspecting the faceplate and back plate for damage; inspecting and cleaning the diaphragm; disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit.The customer indicated that she was not aware that the membrane came off of the valve for cleaning, but that she did replace the membrane.Troubleshooting did not identify a specific failure.The customer was sent a replacement pump along with 21mm breast shields, and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on (b)(6) 2018 to get additional information, with no response.On (b)(6) 2018 the customer responded via email and indicated that she developed mastitis on (b)(6) 2017 and again on (b)(6) 2018 and was prescribed an antibiotic, which she just finished.She indicated that the replacement pump was working without issue and her mastitis was resolved.Based on the results of (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 0.008% for the period of (b)(6) 2013 to (b)(6) 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." 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) 2018, the customer alleged to medela llc that the suction on her pump in style breast pump was slowing down and she was getting clogged ducts on and off, for which she was prescribed an antibiotic.She indicated that the clogged ducts were due to multiple issues, not just related to the pump.
 
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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
jan kloiber
1101 corporate drive
mchenry, IL 60050
MDR Report Key7305627
MDR Text Key101239471
Report Number1419937-2018-00066
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number57081
Device Catalogue Number57081
Was Device Available for Evaluation? No
Distributor Facility Aware Date02/07/2018
Date Manufacturer Received02/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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