MAUDE Adverse Event Report: NAYA HEALTH BREAST PUMP

Device Problem Device Inoperable (1663)

Patient Problems Feeding Problem (1850); Pain (1994); No Code Available (3191)

Event Date 08/25/2017

Event Type  Injury  

Event Description

Naya health breast pumps do not work.It caused me severe pain and engorgement to have a non functional piece of medical equipment and caused severe loss of birth wight of my daughter due to her inability to breastfeed the first few months of her life.I was depending on this pump to feed her.Postpartum when using equipment.

• Brand Name: BREAST PUMP
• Type of Device: BREAST PUMP
• Manufacturer (Section D): NAYA HEALTH
• MDR Report Key: 7048596
• MDR Text Key: 92632101
• Report Number: MW5073456
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 61