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

Model Number 101037980

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

Patient Problem No Code Available (3191)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

The customer was sent replacement parts and accessories.On 02/05/2020, the customer called back and alleged to medela llc that her freestyle flex breast pump would not turn on, so she rented another pump to use.Because she was not able to be mobile with the rented pump, she pumped less often, causing her to get mastitis, for which she started antibiotics on (b)(6) 2020.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 02/14/2020, the customer indicated that the replacement pump was working without issue and the mastitis was resolved.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 01/30/2020, the customer alleged to medela llc that there was a milk backup when using her freestyle flex breast pump.

• 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
• Manufacturer Contact: jan kloiber ; lattichstrasse 4b; baar zug 6341, ; WZ
• MDR Report Key: 9769282
• MDR Text Key: 194936826
• Report Number: 1419937-2020-00015
• Device Sequence Number: 1
• Product Code: HGX
• 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: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101037980
• Device Catalogue Number: 101037980
• Device Lot Number: 160120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other