FDA Adverse Event Injury Summary report: N

SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER

MDR report key: 7327131 · Received March 8, 2018

Report

Report Number
MW5075773
Event Type
Injury
Date Received
March 8, 2018
Date of Event
March 1, 2018
Report Date
March 7, 2018
Manufacturer
DAGAMMA, INC.
Product Code
DRT
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

HELLO, I AM PREGNANT AND I AM AT 13 WEEKS OF PREGNANCY. MY SISTER LIVES IN US/(B)(6). LAST WEEK, SHE CAME OVER TO VISIT ME AND BROUGHT ME A PRODUCT WHICH SHE PURCHASED ON THE (B)(6) WEBSITE. THE PRODUCT SEEMS TO BE SOLD TO MANY PREGNANT LADIES. THE DEVICE IS CLAIMING THAT IT ALLOWS YOU TO HEAR YOUR UNBORN BABY'S HEARTBEAT. I TRIED SPOTTING THE BABY FOR 2- MINS WITH NO SOUND. THEN I STARTED SEARCHING THE INTERNET FOR INSTRUCTION FOR USE AND I WAS SHOCKED WHEN I SAW A NOTE BY FDA ON THIS DEVICE. THE NOTE CLEARLY INDICATES THAT THERE COULD BE HARM TO THE BABY AND ADVICE AGAINST THE USE OF THIS. AFTER READING THAT ARTICLE AND ALSO THE FACT THAT I COULD NOT SPOT MY BABY, I HAD A VERY BAD PANIC ATTACK AND FELT THAT I HAD HARMED MY BABY. WE RUSHED TO THE HOSPITAL AND SINCE I RECENTLY HAD AN ULTRASOUND, MY DR RECOMMENDED ME NOT TO GO THROUGH ANOTHER ULTRASOUND. MY DR ALSO MENTIONED THAT THE DEVICE HAS WAVES WHICH COULD POTENTIALLY BE HARMFUL FOR BABIES. I AM REALLY UNABLE TO UNDERSTAND IF A PRODUCT IS TAGGED HARMFUL FOR BEING USED WITHOUT A MEDICAL EXPERIENCED PERSON, HOW COULD IT BE EASILY BOUGHT AND SHIPPED IN ONE DAY. WE TRIED TO REACH (B)(6) ON THIS AND WE CHATTED WITH AN ONLINE AGENT. THEY SIMPLY TOLD ME THAT THEY WILL TAKE ACTION, THAT WAS LAST WEEK AND NOBODY GOT BACK TO US. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
168066 SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER DRT DAGAMMA, INC. SOLOLINE B

Patients

Seq Age Sex Outcome Treatment
1 32 YR Life Threatening