MAUDE Adverse Event Report: MEDELA LLC HARMONY MANUAL BREASTPUMP; PUMP, BREAST, NON-POWERED

Model Number 67186

Device Problem Failure to Power Up (1476)

Patient Problem Injury (2348)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the pump and accessories.The customer confirmed that there was no visible damage to the parts and that the breast shields were correctly sized.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler to get additional information, with no response as of the date of this report.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

Event Description

On (b)(6) 2019, the customer alleged to medela llc her sonata breast pump was not powering on and, as a result, she was using a harmony breast pump, which was tearing her nipples and causing them to bleed.The customer indicated that she was using the harmony breast pump in stimulation mode, because the expression phase hurt and was too strong, causing her nipples to rip.The customer indicated that she did not experience any pain while using the sonata breast pump.The customer further alleged that she was prescribed a nipple ointment and compresses by her lactation consultant.

• Brand Name: HARMONY MANUAL BREASTPUMP
• Type of Device: PUMP, BREAST, NON-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: 8739633
• MDR Text Key: 149375388
• Report Number: 1419937-2019-00088
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823840
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67186
• Device Catalogue Number: 67186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/27/2019
• 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