SONOLINE B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for SONOLINE B manufactured by Dagamma Inc..

Event Text Entries

[93207770] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073582
• MDR Report Key: 7063440
• Date Received: 2017-11-28
• Date of Report: 2017-11-24
• Date of Event: 2017-11-20
• Date Added to Maude: 2017-11-28
• 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
• 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
• Generic Name: SYSTEM IMAGING
• Product Code: KNG
• Date Received: 2017-11-28
• Model Number: B
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DAGAMMA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-11-28