MAUDE Adverse Event Report: CONTEC MEDICAL SYSTEMS BABYDOPPLER

Model Number SONO LINE B

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

Patient Problem Nausea (1970)

Event Date 09/06/2018

Event Type  Injury  

Event Description

I purchased a product as a gift for my sister who is expecting living in (b)(6).I came across the product on advertisement on (b)(6) advertising as a cool product for pregnant ladies to hear their unborn baby.I purchased the product through a us supplier and was shipped to my sister in 3 days.She used the product and she had symptoms of severe nausea.She took the device to her doctor and she was advised strongly against the use of this device as it has emission of waves.It was a real shock to her and to me as the person who would be to blame for anything bad happening to baby.I searched online and by surprise, i saw the fda of this device only allows the device to be used by prescription.No where on the website i was asked to provide prescription or event the smallest hint.I tried to reach out the supplier by email, but no hope or response.We have been severly traumatized by this incident.Hope this prevents other folks going through the same bad experience.Www.Babydoppler.Com.

• Brand Name: BABYDOPPLER
• Type of Device: BABYDOPPLER
• Manufacturer (Section D): CONTEC MEDICAL SYSTEMS
• MDR Report Key: 7889327
• MDR Text Key: 120976974
• Report Number: MW5079885
• Device Sequence Number: 1
• Product Code: KNG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SONO LINE B
• Device Catalogue Number: B
• 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