Blank fields on this form indicate the information is unknown or unavailable.Address: address: (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, 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, during a treatment for postpartum hemorrhage [pph] after a cesarean section, a cook bakri postpartum balloon with rapid instillation components' balloon leaked from a reported pinhole leakage.The maternal uterine contraction was weak after the cesarean section.A blood loss of approximately 400ml occurred before the device failure.The balloon was filled with 300 ml of saline to stop the bleeding through the uterine incision.The patient was returned to the ward after her vital signs were observed to be stable.Dark red blood water was found to flow out in the vagina of the patient as well as dark red blood on the puerperal pad.The height of the uterine cavity/ fundus height were found to be decreased.After removing the balloon, the balloon was found to have only about 80ml of fluid left and a small hole was found on the upper end of the balloon.At this point, the patient has successfully stopped bleeding.No adverse effect reported.The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.
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Investigation evaluation as reported, during a treatment for postpartum hemorrhage [pph] after a cesarean section, a cook bakri postpartum balloon with rapid instillation components' balloon leaked from a reported pinhole leakage.The maternal uterine contraction was weak after the cesarean section.A blood loss of approximately 400ml occurred before the device failure.The balloon was filled with 300 ml of saline to stop the bleeding through the uterine incision.The patient was returned to the ward after her vital signs were observed to be stable.Dark red blood water was found to flow out in the vagina of the patient as well as dark red blood on the puerperal pad.The height of the uterine cavity/ fundus height were found to be decreased.After removing the balloon, the balloon was found to have only about 80ml of fluid left and a small hole was found on the upper end of the balloon.At this point, the patient has successfully stopped bleeding.No adverse effect reported.The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.The complaint device was not returned; therefore, no functional testing or visual inspections could be performed.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed 3 other complaints associated with the complaint device lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling; the ifu [t_j-sosr_rev4; 'bakri postpartum balloon'] supplied with the device states the following in consideration of the reported failure mode: 'how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.' the complaint was confirmed based on customer testimony.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, 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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