B3 - unspecified date in (b)(6) 2023.E1- customer (person): postal code = (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.
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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: cook was notified of an incident involving a cook bakri postpartum balloon.As reported, the blue stopcock fell off the device.It is not known if the balloon was placed transvaginally or transabdominally after a cesarean delivery.The inflation volume was not known, as the balloon deflated once the stopcock separated.The customer has reported that this could possibly had occurred due to user error, because the stopcock was not secured prior to inflation.No adverse effects were reported.No additional information has been provided.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for the complaint device could not be conducted nor could a search of other complaints associated with the complaint device lot number be completed due to the lack of production lot information from the user facility.Review of the customer testimony and relevant manufacturing documents does not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_j-sosr_rev4 ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.
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