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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAGAMMA, INC. BABYDOPPLER SONOLINE B
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DAGAMMA, INC. BABYDOPPLER SONOLINE B Back to Search Results
Medical Device Problem Codes Product Quality Problem (1506); Use of Device Problem (1670)
Health Effect - Clinical Code Cramp(s) (2193)
Date of Event 09/25/2019
Type of Reportable Event Serious Injury
Event or Problem Description
We are expecting a baby and we are at week (b)(6).My wife received a babyshower gift from one of our relatives which she purchased the product from a us based company.The product was shipped to their address and subsequently to us.The product is a fetal doppler which is advertised and promoted to help parents to listen to the fetal heartbeats.When we received the product we used it, but after 20 mins of trying we did not hear anything.My wife was quite panicking and she felt a cramp.We ended up going to the clinic.Our drs advised heavily against the use of this device.We contacted the seller and filed a complaint and they promised to get back to us with a personal safety or compliant.However there was no response.We searched more on internet and we came to know some horrible stories of the harm this deice could potentially inflict on babies.Also on fda database we found out that this device was approved for sales to medical practitioners not as an otc.We purchased the product from this website: (b)(6) (in product search if you put sonoline) this product will show up.Best regards.Fda safety report id# (b)(4).
 
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Brand Name
BABYDOPPLER SONOLINE B
Common Device Name
BABYDOPPLER SONOLINE B
Manufacturer (Section D)
DAGAMMA, INC.
MDR Report Key9193098
Report NumberMW5090388
Device Sequence Number14228093
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) 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/11/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Congenital Anomaly;
Patient Age38 YR
Patient Weight64
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