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

Model Number 101037980

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

The customer reset the battery and there was no change with the suction releasing while pumping.The customer was sent a replacement pump along with a manual pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 10/18/2021, the customer indicated that the replacement pump was working well but she did not have a chance to return the old one yet as she was dealing with mastitis for which she was prescribed antibiotics.In follow up with the customer on (b)(6) 2021, the customer indicated that her mastitis seems to be ok and the pump has been returned.Based on the results of our internal investigation (reference number (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 of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However in this case, the mother's mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

On (b)(6) 2021, the customer alleged to medela (b)(6) that her freestyle flex breast pump was suctioning but not releasing.

• 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: dave kurudza ; 1101 corporate drive; mchenry, il ; 4328316
• MDR Report Key: 12736469
• MDR Text Key: 279539677
• Report Number: 1419937-2021-00101
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451379807
• UDI-Public: 020451379807
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/02/2021
• 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: 178691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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