PUMP IN STYLE ADVANCED ON-THE-GO TOTE 101036449

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for PUMP IN STYLE ADVANCED ON-THE-GO TOTE 101036449 manufactured by Medela Llc.

Event Text Entries

[177677513] 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. Following troubleshooting, the customer indicated the troubleshooting did not resolve the issue. The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation. The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report. 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 (b)(4)% 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. " 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.
Patient Sequence No: 1, Text Type: N, H10


[177677554] On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump had low suction. She additionally alleged that she developed mastitis four (4) times, had taken antibiotics for the first two (2) occurrences, but for the last two occurrences she did not go to the doctor and the mastitis went away on its own.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419937-2020-00004
MDR Report Key9626838
Report SourceCONSUMER
Date Received2020-01-24
Date of Event2020-01-07
Date Mfgr Received2020-01-07
Date Added to Maude2020-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAN KLOIBER
Manufacturer Street1101 CORPORATE DRIVE
Manufacturer CityMCHENRY IL 60050
Manufacturer CountryUS
Manufacturer Postal60050
Manufacturer Phone8004358316
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUMP IN STYLE ADVANCED ON-THE-GO TOTE
Generic NamePUMP, BREAST, POWERED
Product CodeHGX
Date Received2020-01-24
Model Number101036449
Catalog Number101036449
Lot Number453990
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDELA LLC
Manufacturer Address1101 CORPORATE DRIVE MCHENRY IL 60050 US 60050


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-24

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