Blank fields on this form indicate the information is unknown or unavailable.E1: name and address - phone: (b)(6).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.
|
As reported, during a postpartum hemorrhage (pph), a 'cook bakri postpartum balloon with rapid instillation components' balloon would not inflate and leaked into its collection bag.During upstream testing, the balloon partially inflated.A new device was used for the procedure.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
|
Event summary: as reported, during a postpartum hemorrhage (pph), a 'cook bakri postpartum balloon with rapid instillation components' balloon would not inflate and leaked into its collection bag.During upstream testing, the balloon partially inflated.A new device was used for the procedure.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.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 (qc) procedures.The complaint device was not returned for evaluation.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 from the available information.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.
|