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Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = unknown.H3: device evaluated by mfg = other (code unspecified, describe in h10) (81) = device returned, currently under investigation.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, that a death or serious injury occurred, nor 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, following a cesarean section due to placental abruption, a patient lost 480ml of blood and a 'cook bakri postpartum balloon with rapid instillation components' was placed transvaginally to achieve hemostasis.Upon placement of the device and gauze, a small leak near the drainage injection tube was noted.The user applied waterproof tape to the area of the leak and hemostasis was achieved.The patient lost an additional 70ml of blood following the device issue.No blood transfusion was required and no metal tools were used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, following a cesarean section due to placental abruption, a patient lost 480ml of blood and a 'cook bakri postpartum balloon with rapid instillation components' was placed transvaginally to achieve hemostasis.Upon placement of the device and gauze, a small leak near the drainage injection tube was noted.The user applied waterproof tape to the area of the leak and hemostasis was achieved.The patient lost an additional 70ml of blood following the device issue.No blood transfusion was required and no metal tools were used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures.Additionally, a visual inspection and functional test of the device was conducted.The complaint device was returned for evaluation.The laboratory team was unable to test the balloon due to the inflation port not being standard and unable to be removed.Water was left in the balloon, and the balloon was manipulated to check for leaks.Nothing was observed to escape the balloon area.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records found no other complaints reported for the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state on how to supply, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook concluded a definitive cause of the event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.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, that a death or serious injury occurred, nor 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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