BABY DOPPLER ULTRALINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BABY DOPPLER ULTRALINE manufactured by Dagamma Inc..

Event Text Entries

[107463328] We are pregnant (15th week) since we had miscarriage case before i was worried and was trying to educate myself on internet on related topics. I came across an ad about a product which is for home use and can help us to deal with the stress. We purchased the product online and was shipped to our residence in 4 days. The device claims to help parents to spot the baby during pregnancy and listen to the heartbeat. I tried using the product for 20 minutes with no luck. I tried the same process 3 more times one on the same day and twice in following days. I was panicked and we rushed to my ob office. My doctor informed me not to use the device at all since the waves made by the device could potentially harm the baby leading to birth defect in the form of hearing impairment or brain damage. It was really devastating to hear that and we started research on the net and to our surprise we saw that there is warning from fda against the use of this device. We called the supplier asking for more information on this and there was no luck. There are 100s of reviews from customers on the same side effect and anxiety on different mom forums. We have discarded the product but we aimed to prevent the same distress to other expecting parents. Retailer which we got the product from: www. Babydoppler. Com. Fda link on the subject https://www. Fda/gov/forconsumers/consumerupdates/ucm095508. Htm. Where we got the product from: www. Babydoppler. Com.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077012
• MDR Report Key: 7486228
• Date Received: 2018-05-03
• Date of Report: 2018-05-02
• Date of Event: 2018-04-18
• Date Added to Maude: 2018-05-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• 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: BABY DOPPLER
• Generic Name: MONITOR, ULTRASONIC FETAL
• Product Code: KNG
• Date Received: 2018-05-03
• Model Number: ULTRALINE
• 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: BABY DOPPLER
• Generic Name: MONITOR, ULTRASONIC FETAL
• Product Code: KNG
• Date Received: 2018-05-03
• Model Number: ULTRALINE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BABYDOPPLER/DOGAMMA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly	2018-05-03