MAUDE Adverse Event Report: BABY DOPPLER / DAGAMMA INC. SONOLINE B (FETAL DOPPLER); MONITOR, ULTRASONIC FETAL

Model Number SONOLINE B

Device Problems Defective Device (2588); Device Sensing Problem (2917)

Patient Problem Anxiety (2328)

Event Date 01/10/2019

Event Type  Injury  

Event Description

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).

• Brand Name: SONOLINE B (FETAL DOPPLER)
• Type of Device: MONITOR, ULTRASONIC FETAL
• Manufacturer (Section D): BABY DOPPLER / DAGAMMA INC.
• MDR Report Key: 8260724
• MDR Text Key: 133834046
• Report Number: MW5083214
• Device Sequence Number: 1
• Product Code: HGM
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SONOLINE B
• Device Catalogue Number: 0100628055787051
• 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: 68