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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR

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COOK INCORPORATED COOK CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR Back to Search Results
Model Number G19891
Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2019
Event Type  malfunction  
Event Description
The clinical nurse midwife placed the cook cervical ripening balloon successfully, then, when she attempted to remove the stylet, the blue plastic end cover/gripper came detached from the metal stylet, leaving nothing for the clinical nurse midwife to grasp to remove the stylet. She was unable to remove the stylet from the device, necessitating removing the entire device. A different brand cervical ripening balloon was then placed without difficulty. Manufacturer response for catheter, balloon, dilation of cervical canal prior to labor, cook (per site reporter). The representative is meeting with the clinical nurse specialist and planning on meeting with the staff.
 
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Brand NameCOOK
Type of DeviceCATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomingtom IN 47404
MDR Report Key9144998
MDR Text Key160943720
Report Number9144998
Device Sequence Number1
Product Code PON
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG19891
Device Catalogue NumberJ-CRBS-184000
Device Lot Number9855647
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2019
Event Location Hospital
Date Report to Manufacturer10/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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