MAUDE Adverse Event Report: DAGAMMA, INC. SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER

Model Number SOLOLINE B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Anxiety (2328)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Hello, i am pregnant and i am at 13 weeks of pregnancy.My sister lives in us/(b)(6).Last week, she came over to visit me and brought me a product which she purchased on the (b)(6) website.The product seems to be sold to many pregnant ladies.The device is claiming that it allows you to hear your unborn baby's heartbeat.I tried spotting the baby for 2- mins with no sound.Then i started searching the internet for instruction for use and i was shocked when i saw a note by fda on this device.The note clearly indicates that there could be harm to the baby and advice against the use of this.After reading that article and also the fact that i could not spot my baby, i had a very bad panic attack and felt that i had harmed my baby.We rushed to the hospital and since i recently had an ultrasound, my dr recommended me not to go through another ultrasound.My dr also mentioned that the device has waves which could potentially be harmful for babies.I am really unable to understand if a product is tagged harmful for being used without a medical experienced person, how could it be easily bought and shipped in one day.We tried to reach (b)(6) on this and we chatted with an online agent.They simply told me that they will take action, that was last week and nobody got back to us.(b)(6).

• Brand Name: SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER
• Type of Device: SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER
• Manufacturer (Section D): DAGAMMA, INC.
• MDR Report Key: 7327131
• MDR Text Key: 102101877
• Report Number: MW5075773
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SOLOLINE B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR
• Patient Weight: 61