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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTEC MEDICAL SYSTEM CO. LTD. CONTEC POCKET FETAL DOPPLER; MONITOR, ULTRASONIC, FETAL
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CONTEC MEDICAL SYSTEM CO. LTD. CONTEC POCKET FETAL DOPPLER; MONITOR, ULTRASONIC, FETAL Back to Search Results
Model Number FD-200B
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code Anxiety (2328)
Date of Event 04/06/2018
Type of Reportable Event Serious Injury
Event or Problem Description
My cousin purchased the "facelake fd-200b baby heartbeat monitor sound amplifier, listening to unborn baby's heartbeat, movements, kicks and hiccups from (b)(4).After my cousin gifted us the product we tried to use it and were very anxious to listen to our baby's heartbeat.We couldn't find it after several tries and immediately my wife had a panic attack and thought something happened to the baby.We then took the product to our doctor to make sure that everything with the baby was fine and our doctor strongly advised that this item is for professional use and our doctor was wondering where we bought it.Once we got home we did some research of our own and we were shocked to realize that this product is actually not recommended by fda and only available with a prescription.This had me thinking, how could someone on (b)(4) sell a product to the public without a prescription especially when it is harmful without a medical professionals supervision.The device she bought was (b)(4).
 
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Brand Name
CONTEC POCKET FETAL DOPPLER
Common Device Name
MONITOR, ULTRASONIC, FETAL
Manufacturer (Section D)
CONTEC MEDICAL SYSTEM CO. LTD.
MDR Report Key7424840
Report NumberMW5076429
Device Sequence Number2028577
Product Code KNG
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberFD-200B
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/11/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age27 YR
Patient Weight66
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