MAUDE Adverse Event Report: SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER; MONITOR, ULTRASONIC FETAL

Model Number BABYDOPPLER

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

Patient Problem Anxiety (2328)

Event Date 01/18/2018

Event Type  Injury  

Event Description

I purchased this product as i was browsing (b)(4) and i read some customer reviews.The device claims to be using to hear fetus heartbeat in pregnancy.I purchased the device and it was shipped to our address.I used the device 3-4 times then on internet i came across an article by an obstetrician advising strongly against the use of this device even damage to unborn babies.I have called the supplier which is (b)(4) and the staff over the phone were unable to advice me if this device is for home use.As an expecting mom experiencing so much anxiety this device has been marketed without any medical proof and safety.(b)(4) item number is: b073wkdt2h.

• Brand Name: SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER
• Type of Device: MONITOR, ULTRASONIC FETAL
• MDR Report Key: 7263389
• MDR Text Key: 99901805
• Report Number: MW5075189
• Device Sequence Number: 1
• Product Code: KNG
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BABYDOPPLER
• Device Catalogue Number: ASIN NUMBER
• Device Lot Number: B073WKDT2H
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 64