MAUDE Adverse Event Report: SONOLINE; BABYDOPPLER

Model Number B

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

Patient Problem Burn(s) (1757)

Event Date 11/28/2017

Event Type  Injury  

Event Description

I am (b)(6) weeks pregnant - in a forum i came to know about a product called babydoppler - i purchased it online on this website: (b)(6).Company is us based and they shipped it to my address.I used the device as shown on the video in the website - after 15 minutes using the probe trying to spot the baby's heartbeat i had a feeling of burning on my skin - after that i found a burn mark on my skin as big as the size of a coin.I was really afraid of the symptoms - i went to my ob and he told me that this device is widely available but was never approved by fda for use by public.The ultrasound device could create deep heat in tissues and harm the unborn baby.I am extremely desperate, stressful, angry and hopeless.I called the company and could not get any response from them.

• Brand Name: SONOLINE
• Type of Device: BABYDOPPLER
• MDR Report Key: 7079119
• MDR Text Key: 93803299
• Report Number: MW5073720
• Device Sequence Number: 1
• Product Code: KNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Life Threatening; Other
• Patient Age: 34 YR
• Patient Weight: 68