MAUDE Adverse Event Report: MEDELA AG FREESTYLE BREAST PUMP- SINGLE; PUMP,BREAST,POWERED

Model Number 101034712

Device Problems Battery Problem (2885); Gas/Air Leak (2946)

Patient Problem Unspecified Infection (1930)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Because the customer reported her issue through email, customer service requested via an email response that she call so that her issue could appropriately be addressed.In follow up with a complaint handler on 07/02/2018, the customer indicated that she developed mastitis twice, once around (b)(6) 2018 and the second time around(b)(6) 2018 and she was prescribed antibiotics.She indicated via email in her response that she did contact customer service, however, there was no resolution to the product issue, though the antibiotics were working and she was healing.Follow up with the customer is on-going to help resolve the issue.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) 2018, the customer alleged to medela llc that she had two freestyle breast pumps with issues.The first pump motor did not pull out enough milk after feeding her baby and the connectors leaked air and she ended up with mastitis twice.Additionally, her second pump came with a faulty battery.

• Brand Name: FREESTYLE BREAST PUMP- SINGLE
• Type of Device: PUMP,BREAST,POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341, ; SZ
• Manufacturer (Section G): MEDELA AG; lattichstrasse4b; baar zug 6341, ; WZ
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 7735092
• MDR Text Key: 115562843
• Report Number: 1419937-2018-00168
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150499
• 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: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other