MAUDE Adverse Event Report: MEDELA AG FREESTYLE FLEX BREAST PUMP EN FR ES; PUMP, BREAST, POWERED

Model Number 101037980

Device Problems Decrease in Suction (1146); Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

The customer has been requested to contact customer service so that her issue can appropriately be addressed.As of the date of this report, the customer has not done so.In follow up with a complaint handler on 09/09/2020, the customer indicated that she developed mastitis in early (b)(6) and was prescribed an antibiotic.She additionally indicated that she still had clogged ducts and accepted contact by a medela clinician.The customer was contacted by a medela clinician on multiple occasions and responded via email on (b)(6) 2020, stating she still had chronic ducts although they were improving with massage and would reach out later that day.As of the date of this report, the customer has not done so.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." 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) 2020, the customer alleged to medela llc via email that her freestyle flex breast pump had low suction and would get very hot and shut off after 15-20 minutes, which she did not expect with such a high cost pump.She additionally alleged that she had been dealing with clogged ducts and had seen a lactation consultant.

• Brand Name: FREESTYLE FLEX BREAST PUMP EN FR ES
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer Contact: mike mcandrew ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 10619189
• MDR Text Key: 209582712
• Report Number: 1419937-2020-00110
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451379807
• UDI-Public: 020451379807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101037980
• Device Catalogue Number: 101037980
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• 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