MAUDE Adverse Event Report: MEDELA LLC APDP BASE BP EN ES USA; PUMP, BREAST, POWERED

Model Number 101035078

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

Patient Problem Pain (1994)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Customer service sent the customer the 24 mm personal fit flex breast shields to try.In follow up with a complaint handler on (b)(6) 2019, the customer indicated that she switched to the freestyle breast pump and it has made a big difference, as well as the 24 mm flex shields.The customer indicated that she believes the pumping action on the freestyle is much more gradual as opposed to the pump in style, which feels very mechanical and unnatural.The customer indicated that she developed some blistering and bleeding at the beginning, but then developed mastitis for which she received an antibiotic.The customer indicated that she was still very sore and her nipples were still very tender to the touch but she thinks that will take some time to resolve.The customers breast shields were returned and evaluated on 10/01/2019.The breast shields passed a visual inspection and were found to be acceptable.Refer to attached product evaluation.The instructions for use provides instructions for breast shield sizing, including reference to medelabreastshields.Com and referral to a lactation consultant for assistance in choosing the correct size breast shield.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 (b)(6) 2013 to (b)(6) 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.(b)(4).

Event Description

On (b)(6) 2019, the customer alleged to medela llc that she was using the personal fit 24 mm and 27 mm breast shields with her pump in style breast pump and pumping had been extremely painful.She further alleged that a lactation specialist told her that the 24 mm breast shields were the correct size and that she uses the same breast shields without issue with a manual pump.The customer indicated that there was no issue with the suction on the pump.

• Brand Name: APDP BASE BP EN ES USA
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 9224272
• MDR Text Key: 163924703
• Report Number: 1419937-2019-00139
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• 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: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101035078
• Device Catalogue Number: 101035078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 09/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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