UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-29 for UNK * manufactured by Unk.

Event Text Entries

[20238442] Stillbirth of pt. The mother had something like 5 or 6 sonograms during their pregnancy. Reporter viewed the second sonogram and was curious why the baby was jumping around in the womb like a balloon, or like it was attached to a bungy cord. The tech said it was due to the baby responding to the clicking sound of the sonogram. The tech continued the sonogram for perhaps 15 minutes, trying to view all the items she needed to on her checklist. All the while the baby continued bouncing all over the womb. It was disturbing to rptr to watch because rptr could see the baby was being disturbed, too. Reporter objected to the parents about this procedure and advised them not to have any more sonograms. They ignored reporter of course. Believing the doctor knew what she was going. More sonograms continued, as the doctor needed to complete all the items on the checklist. At the end of the gestation period, the mother went into labor and pt was stillborn... The cord had a knot in it. In addition, another family member, who viewed the actual birth, said the cord was wrapped 'round and round the baby'. In reporter's layman sense of dynamics, with all those sonograms, and the baby's hyper response to the "clicking" sound of the sonograms, it seems inevitable that the baby would become entangled in the umbilical cord. Needless to say, reporter is grieving over this and angry that the medical profession and the parents ignored obvious warning signs. Reporter read an ap article about the inappropriate use of ultrasound.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1031505
MDR Report Key518002
Date Received2004-03-29
Date of Report2004-03-29
Date of Event2004-01-10
Date Added to Maude2004-03-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameULTRASOUND
Product CodeLXE
Date Received2004-03-29
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key507038
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2004-03-29

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