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

Model Number 101034712

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

Patient Problem Pain (1994)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Customer service attempted to assist customer with information on breast shield sizing and how to find a lactation consultant, but the call was disconnected.In follow up with a complaint handler on (b)(6) 2019, the customer indicated that there was nothing wrong with her breast pump and she has various sizes of breast shields, but did not know which size to use.She additionally indicated that the most milk is expressed using the 21mm breast shields, but they hurt her nipples and she has to use a prescription ointment after pumping.The customer was offered and accepted contact by a medela clinician.In follow up with the medela clinician on (b)(6) 2019, the customer indicated that she was pumping twice as much milk when using the bustier for 10-15 minutes and is more comfortable with pumping.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).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.

Event Description

On 10/18/2019, the customer alleged to medela llc that she was concerned about the milk being expressed when using the personal fit 21mm breast shields with her pump in style breast pump.She additionally alleged that the 21mm breast shields hurt her nipples, though the 24mm breast shields felt better.

• 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; lattichstrasse 4b; baar zug 6341 ; SZ
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 9329696
• MDR Text Key: 167614188
• Report Number: 1419937-2019-00148
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• 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: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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