MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: compliance and customer service coordinator.Pma/510k # k170622.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, the user experienced "broken ball at the time of water intake-water comes out through hole, i requested a new balloon for the procedure." (unofficial translation of hand written information reported).The patient experienced no adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of the occurrence.No unintended section of the device remained inside the patient's body.Additional details regarding the patient and the event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, instructions for use (ifu), and quality control of 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the quality control procedures, and overall device master record were conducted, and no gaps were discovered.Additionally, and ifu is provided with the device noting all necessary warnings, precautions, indications, and contraindications.Based on the information provided and no product returned, investigation has concluded a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8640243
• MDR Text Key: 146078779
• Report Number: 1820334-2019-01265
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210913(10)9161163
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/13/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 9161163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR