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 2017-11-22 for SONOLINE B manufactured by Contec Medical Systems.

Event Text Entries

[92872361] My wife came across a product sold on (b)(6) usa website indicating and promoting that the use of device will reduce anxiety in pregnant moms. Since we had a miscarriage before and my wife was anxious of not feeling the baby movement, we purchased this product from (b)(6) online and was delivered to our address. My wife used the device as instructed - putting the probe on her belly and trying to spot the baby heartbeat. After 10 minutes my wife had a feeling of deep tissue burn on her belly. We immediately stopped using the device. I searched the internet on this matter and came to know clearly that this device is for otc sales. It is not even recommended by obstetricians and doctors! This is given the fact that product also carries the sign of recommended by doctors on the package! With further research, i came to know that the use of this device can create heating in tissues and create harm to fetus. Also fda had approved this product for professional use not home use! We are in the process of getting a legal advise and assign a lawyer on the case since we incurred severe panic attacks and still we are feeling shameful for a possible harm to our baby. I would like your urgent attention to this case to help other expecting parents. I am here providing a link that clearly supply this product and promote it as safe use! And worse recommended by doctors: (b)(4). Also please check (b)(4) and search for sonoline b, you see the product easily listing there for purchase and free delivery. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073516
MDR Report Key7052349
Date Received2017-11-22
Date of Report2017-11-20
Date of Event2017-11-08
Date Added to Maude2017-11-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSONOLINE B
Generic NameMONITOR, ULTRASONIC, DIAGNOSTIC
Product CodeKNG
Date Received2017-11-22
Model NumberB
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCONTEC MEDICAL SYSTEMS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-22

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