MAUDE Adverse Event Report: DAGAMMA INC. SONOLINE; SYSTEM IMAGING

Model Number B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Rash (2033)

Event Date 11/20/2017

Event Type  Injury  

Event Description

My sister asked me to purchase this product in (b)(6) website - the product was purchased easily and shipped to our place.The product indicated on the box as safe and recommended by doctors.My sister is pregnant at (b)(6).The device claims to be helping relieving anxiety in pregnant ladies helping them to listen to the unborn baby heartbeat.My sister tried using the device for 15 minutes to spot the heartbeat - she got a feeling of rash and overheating on her skin and her skin burnt - she immediately had to go to the hospital - her obstetrician advised strongly against the use of this device.The doctor researched further and found out clearly fda has approved this product only for professional use.This is despite the fact that (b)(6) is easily advertising and selling the product.With further research we came to know - that device creates deep tissue heating and can lead to permanent damage in unborn babies including permanent brain damage and loss of hearing.We would need fda immediate help and attention to this matter.

• Brand Name: SONOLINE
• Type of Device: SYSTEM IMAGING
• Manufacturer (Section D): DAGAMMA INC.
• MDR Report Key: 7063440
• MDR Text Key: 93207770
• Report Number: MW5073582
• Device Sequence Number: 1
• Product Code: KNG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B
• 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: 28 YR
• Patient Weight: 55