MAUDE MDR 7458943

MDR report key
7458943
Report number
MW5076723
Event key
0
Event type
3
Date of event
2018-04-03
Date received
2018-04-25
Adverse event
0
Product problem
0
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SONOLINE B HEARTBEAT MONITORMONITOR, ULTRASONIC, FETALCONTEC MEDICAL SYSTEMS CO., LTD.KNGB073WKDT2HB073WKDT2HI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-2501. R

Event Narratives#

D

Patient 1

MY WIFE AND I ARE EXPECTING OUR FIRST BABY. WE WERE ON AMAZON LOOKING FOR A BABY REGISTRY IDEA AND WE CAME ACROSS THIS PRODUCT WHICH PROMOTES THAT YOU CAN HEAR YOUR BABY HEARTBEAT AT HOME WHENEVER YOU LIKE. THE IDEA WAS FUN SO AFTER READING ALL THE REVIEWS ON AMAZON, WE PURCHASED IT AND GOT IT IN TWO DAYS. THE PRODUCT CAME ALONG WITH AN ULTRASOUND GEL WHICH WE USED IT. WE TRIED FOR 20-30 MINS TO SPOT THE HEARTBEAT WITH NO LUCK. AT THIS STAGE WE WERE ABSOLUTELY SHAKING TO OUR BONES AS WE THOUGHT WE MIGHT HAVE LOST OUR BABY (SINCE WE HAD BABY LOSS BEFORE). WE RUSHED TO THE CLINIC FOR A DR VISIT. SHE TOLD US BABY IS OK AND SHE STRONGLY ADVISED AGAINST THE USE OF THIS DEVICE AS IT HAS RADIATION. WE CAME HOME AND STARTED RESEARCHING ONLINE AND TO OUR SURPRISE WE FOUND THAT THIS DEVICE IS NOT SUPPOSED TO BE USED BY PEOPLE AT HOME, IS A MEDICAL DEVICE REQUIRED TO BE OPERATED WITH LICENSED PROFESSIONALS. THE PRICE COULD POTENTIALLY HARM UNBORN BABIES IS OVERUSED AND ALSO CAN CAUSE BIRTH DEFECT (INCLUDING HEARING IMPAIRMENT.) WE CONTACTED AMAZON CUSTOMER SUPPORT WITH THE HOPE THAT OTHER PEOPLE WILL NOT GO THROUGH THE SAME TRAUMA BUT SEEMS THAT AMAZON STAFF ARE JUST HANDLING GENERAL INQUIRES. THIS LINK IS FROM FDA SITE WARNING ON THAT HTTPS://WWW.FDA.GOV/FORCONSUMERS/CONSUMERUPDATES/UCM095508.HTM 10 REASON AGAINST THE USE AT HOME HTTPS://WWW.MAMANATURAL.COM/FETAL-HEART-MONITOR-10-REASONS-TO-STAY-AWAY.