MAUDE Adverse Event Report: UNKNOWN TOMMEE TIPPEE WEARABLE BREAST PUMP; PUMP, BREAST, NON-POWERED

Patient Problem Breast Discomfort/Pain (4504)

Event Date 03/30/2024

Event Type  Injury  

Event Description

Using the tommee tippee wearable breast pump, it was working ok but i wasn't experiencing the same output as i did with my main pump so i got help with trouble shooting the problems and concluded the device was working i just changed my insert size.Sometime after i got it fixed there was an update, the next use after this update the suction was so painful it put me in tears.I watched the youtube videos from the natural lioness that mentioned this was a common complaint after the update.The pain was too intense for me to further troubleshoot.

• Brand Name: TOMMEE TIPPEE WEARABLE BREAST PUMP
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19212121
• MDR Text Key: 341489852
• Report Number: MW5154416
• Device Sequence Number: 1
• Product Code: HGY
• 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: 04/24/2024

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White