BABYDOPPLER SONOLINE BABYDOPPLERB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for BABYDOPPLER SONOLINE BABYDOPPLERB manufactured by Dagamma Inc..

Event Text Entries

[100468460] Hi, my husband and i are expecting our very first baby. I am at week (b)(6) of my pregnancy. On facebook i came across a product which was advertised through a u. S based company. The product is basically promoting the use of this device to release stress. I checked the company site and read the review of the people who have used this device. Similar product is also available on (b)(6). With all this, i convinced myself that the use will be helpful to me (since my sister recently had a miscarriage). I purchased the unit and used as instructed. First i was not able to defect the baby's heartbeat. After like 20 mins, i could get the reading. The problem was the day after using the device, i started feeling severe cramp like pain in my stomach. This happened couple of times. The day after i tried the device so desperately for almost one hour and could not spot any heartbeat. It has been the most horrible feeling that i have ever experience. Then i started reading on the internet and i found that fda has warned against the use of that and potential harm to baby. I felt devastated and blamed myself for harming my baby. The day after we went to emergency - our ob checked and informed that luckily the baby is ok, however, she advised us against the use of the device. As a customer when we / i come across a product which is so readily available and even has the claim of dr recommendation on the package. How could i even suspect that the device is harmful. When the product is sold and shipped easily from a company in usa and i can receive it in 2-3 days. My husband is an attorney in law and we sent a letter to company address listed on the website. Explaining the situation and asking for response. We did not hear anything back after 2 months. I feel obliged to care for other ladies not to enter such a horror. Here is fda link of the product. Here is the link of the company we purchased the product (b)(6). Here is same products available through other retailers: (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075306
• MDR Report Key: 7276158
• Date Received: 2018-02-15
• Date of Report: 2018-02-14
• Date of Event: 2018-01-05
• Date Added to Maude: 2018-02-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: BABYDOPPLER SONOLINE
• Generic Name: FETAL DOPPLER
• Product Code: KNG
• Date Received: 2018-02-15
• Model Number: BABYDOPPLERB
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: DAGAMMA INC.

Device Sequence Number: 1

• Brand Name: BABYDOPPLER SONOLINE
• Generic Name: FETAL DOPPLER
• Product Code: KNG
• Date Received: 2018-02-15
• Model Number: BABYDOPPLERB
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUMMIT DOPPLER SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly; 2. Life Threatening	2018-02-15