MAUDE Adverse Event Report: CHIARO TECHNOLOGY LIMITED ELVIE DOUBLE BREAST PUMP; PUMP, BREAST, POWERED

Device Problem Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Superficial (First Degree) Burn (2685)

Event Date 01/29/2022

Event Type  Injury  

Event Description

It's the elvie double electric breast pump.It got hot to the point it burned me and left marks/bruises on my breasts.Fda safety report id # (b)(4).

• Brand Name: ELVIE DOUBLE BREAST PUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): CHIARO TECHNOLOGY LIMITED
• MDR Report Key: 13446276
• MDR Text Key: 285096479
• Report Number: MW5107192
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian