MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 57063

Device Problem Increase in Suction (1604)

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump and 27mm breastshields and return of her original pump and breastshields were requested for testing/evaluation.In follow up with a complaint handler, on (b)(6) 2018 the customer indicated that she was prescribed a cream.In further follow up with the customer, on (b)(6) 2018 she indicated that the cream was an all purpose nipple ointment (apno) containing antibiotics.She indicated that she was also experiencing itching on her breasts and did not know if it was due to healing.The customer requested consultation by a medela clinician, who was in contact with the customer on (b)(6) 2018.During that contact, the customer indicated that she continues to use the apno and the clinician discussed causes for nipple itching as they heal.The clinician noted that the customer does not appear to have any signs consistent with a thrush infection.The clinician ordered a set of soft shells for sore nipples for the customer to use in conjunction with the apno and provided the customer with use instructions, which the customer indicated she understood.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.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

Event Description

On (b)(6) 2018, the customer alleged to medela (b)(4) that the suction was too high on her pump in style breast pump, even on the lowest vacuum setting, and it was causing her pain and blisters on her nipples.She was instructed by her lactation consultant to use a larger size breast shield, but that did not resolve the issue.She was using a 24mm breast shield on one breast and a 27mm on the other.

Manufacturer Narrative

The device was returned with the customer's parts and accessories and it was noted that the returned membrane was non-medela, the breast shields and tubing were dirty and the tubing was broken/damaged.Per procedure related to receipt of non-medela product, the device was evaluated with a lab kit on 04/17/2018 and it passed suction and cycle specifications.Refer to attached evaluation.The customer's report of high suction could not be confirmed.[(b)(4)].

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7422736
• MDR Text Key: 105235867
• Report Number: 1419937-2018-00099
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 440468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/29/2018
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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