Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Vacuum-Assisted Delivery Device Precautions Outlined In Health Advisory

This article was originally published in The Gray Sheet

Executive Summary

FDA is recommending in a public health advisory on vacuum-assisted delivery devices that individuals responsible for post-natal care be made aware of births in which the device has been used so "they can monitor the infant for signs of complications."

You may also be interested in...



Vacuum-Assisted Delivery Safety Affirmed By Study Data, Panel Review

The majority of serious fetal injuries and fatalities associated with a vaginal-assisted delivery device procedure occurred before the device was applied or resulted from physician urgency or error, according to an FDA-sponsored study

Vacuum-Assisted Delivery Safety Affirmed By Study Data, Panel Review

The majority of serious fetal injuries and fatalities associated with a vaginal-assisted delivery device procedure occurred before the device was applied or resulted from physician urgency or error, according to an FDA-sponsored study

FDA Warning To Hospital For MDR Violations Implicates Vacuum Assist Device

Kaweah Delta District Hospital intends to discuss with FDA whether it violated medical device reporting requirements by failing to submit a report on an infant death possibly caused by a fetal vacuum extractor and cited in an Aug. 10 FDA warning letter to the hospital.

Related Content

UsernamePublicRestriction

Register

MT010129

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel