SONOLINE B (FETAL DOPPLER) 0100628055787051

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for SONOLINE B (FETAL DOPPLER) 0100628055787051 manufactured by Baby Doppler / Dagamma Inc..

Event Text Entries

[133834046] I am pregnant and i am at week (b)(6) of my pregnancy. I came across an advertisement on the internet about a device to check the fetus health at home by listening to the baby heartbeat. I purchased the product from a u. S supplier on the internet and received it in 4 days at the price of (b)(6). We tried the product at home as per instruction in the box - i was not able to detect the baby heartbeat, and i tried this for over 20 minutes. Then i felt a bit of anxiety as the device probe (the part on stomach was somehow healed. ) then i started searching the net and found a shocking warning by fda to avoid using this device as the overheating could potentially harm the baby on this link: https://www. Fda. Gov /forconsumers/consumerupdate/ucm095508. Htm; we had to go immediately to our doctor and she also strongly advised against the use. I contacted the company which we bought the product (www. Babydoppler. Com) asking for explanation. They mentioned the product is not a medical unit, however when we search on fda database, we clearly had licensed this product under this license k082480 and the device is with prescription only not over the counter. We have contacted our family lawyer to see if this case can be legally pursed. He advised us to file a report to fda to have a backup for our case. Thanks for your consideration. (babydoppler. Com).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5083214
• MDR Report Key: 8260724
• Date Received: 2019-01-17
• Date of Report: 2019-01-15
• Date of Event: 2019-01-10
• Date Added to Maude: 2019-01-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• 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 Details

• Brand Name: SONOLINE B (FETAL DOPPLER)
• Generic Name: MONITOR, ULTRASONIC FETAL
• Product Code: HGM
• Date Received: 2019-01-17
• Model Number: SONOLINE B
• Catalog Number: 0100628055787051
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BABY DOPPLER / DAGAMMA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-01-17