Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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As reported, during a cesarean section, a cook bakri postpartum balloon with rapid instillation components was placed inside patient in response to massive postoperative bleeding, when the balloon leaked from a pinhole.The device inflated with air prior to use and it functioned normally.The balloon was placed into the uterine cavity and was inflated with 250ml water, however the user discovered insufficient tension.The balloon was removed and a pinhole leak on the left side of the balloon was detected.Another same type device to complete the procedure.According to the initial reporter, a suture needle was used at the same time as the device in question.The total estimated blood loss was 720ml, with 620ml occurring before device use and an additional 100ml afterwards.No blood transfusions were required.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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