MAUDE MDR 7464217

MDR report key
7464217
Report number
MW5076756
Event key
0
Event type
3
Date of event
2018-04-19
Date received
2018-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1WOMB MUSIC HEARTBEAT MONITORMONITOR, ULTRASONIC, FETAL - FETAL DOPPLERSHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.KNGI N

Patients#

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

Event Narratives#

D

Patient 1

I RECENTLY PURCHASED THE WOMB MUSIC HEARTBEAT BABY MONITOR FROM (B)(6) AND AT THE FIRST ATTEMPT OF USAGE SOMETHING SEEMED LIKE IT SHORT CIRCUITED AND SHOCKED MY BELLY REALLY HARD. I WAS IN INTENSE PAIN RIGHT AWAY. IT WAS ALMOST LIKE A SHOCK WITH A BURNING SENSATION. I DIDN'T KNOW THIS AT FIRST BUT AS SOON AS I REPORTED THIS TO MY FAMILY DR, SHE TOLD ME ABOUT THESE FETAL DOPPLERS AND THAT THEY SHOULDN'T BEEN USED WITHOUT A MEDICAL PROFESSIONAL'S SUPERVISION. AT THIS POINT I COULDN'T HELP TO THINK ABOUT THE SAFETY AND HEALTH OF MY BABY. I WAS REALLY WORRIED THAT THE SHOCK COULD HAVE HARMED MY BABY. BUT I WILL NOT KNOW THIS UNTIL MY BABY IS BORN. I WAS CURIOUS AT FIRST WHEN I PURCHASED THIS ITEM THINKING WHETHER IT WOULD NEED A PRESCRIPTION OR NOT. ONLY AFTER I USED IT I REALIZED THAT IT WAS A PRESCRIPTION MEDICAL DEVICE THAT WAS ACTUALLY MANUFACTURED BY (B)(4). MY DR STRONGLY ADVISED NOT TO USE IT AND MAKE SURE TO NEVER BUY SOMETHING LIKE THIS FROM (B)(6). I WAS REALLY WORRIED AND DISAPPOINTED AT THE SAME TIME TO REALIZE THAT SOMETHING LIKE THIS WAS READILY AVAILABLE FOR ME TO PURCHASE.