MAUDE Adverse Event Report: MEDELA LLC MEDELA BREAST PUMP-UNKNOWN

Model Number MEDELA BREAST PUMP-UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

The customer was provided with troubleshooting tips regarding plugged ducts, mastitis and blebs by the medela clinician "behind ask the lc." the customer was contacted on multiple occasions, including in writing, by a complaint handler 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.

Event Description

On (b)(6) 2019, the customer emailed "ask the lc" on the medela breastfeeding website, alleging that she had a clogged duct and was developing mastitis, for which she got antibiotics.She indicated that she tried everything she could think of to break the clog, including heat, massage, hydration, frequent nursing and pumping.She inquired of "ask the lc" if there was more that she could do.

• Brand Name: MEDELA BREAST PUMP-UNKNOWN
• Type of Device: NI
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 9281719
• MDR Text Key: 174947231
• Report Number: 1419937-2019-00142
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MEDELA BREAST PUMP-UNKNOWN
• Device Catalogue Number: MEDELA BREAST PUMP-UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other