MAUDE Adverse Event Report: CHIARO TECHNOLOGY ELVIE; ELVIE PUMP

Model Number EP01

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

Patient Problem Breast Discomfort/Pain (4504)

Event Date 01/20/2024

Event Type  Injury  

Manufacturer Narrative

Chiaro has conducted a literature review (rpt-003219) on the link between breast pumps and mastitis in which several literatures relating to the risk factors and causes of mastitis were reviewed.Although some evidence points to a higher rate of occurrence in women using breast pumps versus those who are breastfeeding, the overall guidance states mastitis was caused by milk stasis and could be cured by effective milk removal, this may suggest that the mastitis was a cause for breast pump use rather than the breast pump use causing mastitis.We can conclude that it is unlikely that a breast pump is the origin of any infection.The customer was sent a replacement and a was requested to return the original pump for evaluation.We have not received the pump back for further investigation.

Event Description

Customer reported on (b)(6) 2024 from uk that the elvie pump has caused her internal nipple injury and causing her bab.

Event Description

Customer reported on 20 jan 2024 from the us that the elvie pump has caused clogged ducts and mastitis.She was prescribed antibiotics.This is a follow up report as the first report was submitted in error.

Manufacturer Narrative

Chiaro has conducted a literature review (b)(6) on the link between breast pumps and mastitis in which several literatures relating to the risk factors and causes of mastitis were reviewed.Although some evidence points to a higher rate of occurrence in women using breast pumps versus those who are breastfeeding, the overall guidance states mastitis was caused by milk stasis and could be cured by effective milk removal, this may suggest that the mastitis was a cause for breast pump use rather than the breast pump use causing mastitis.We can conclude that it is unlikely that a breast pump is the origin of any infection.The customer wants to continue using the pump and troubleshoot the product and replace any parts if required.

• Brand Name: ELVIE
• Type of Device: ELVIE PUMP
• Manufacturer (Section D): CHIARO TECHNOLOGY; 63-66 hatton garden; london, london EC1N 8LE; UK EC1N 8LE
• Manufacturer (Section G): CHIARO TECHNOLOGY; 63-66 hatton garden; london, london EC1N 8LE; UK EC1N 8LE
• Manufacturer Contact: priya gorasia ; 63-66 hatton garden; london, london EC1N -8LE ; UK EC1N 8LE
• MDR Report Key: 18711182
• MDR Text Key: 335470257
• Report Number: 3012098706-2024-00019
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EP01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female