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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK, SILICONE BALLOON HSG CATHETER WITH CLOSED END AND SIDEPORT; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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COOK INCORPORATED COOK, SILICONE BALLOON HSG CATHETER WITH CLOSED END AND SIDEPORT; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number G17471
Device Problem Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Event Description
Balloon would inflate but would not deflate.(this is all the information we have from this event).
 
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Brand Name
COOK, SILICONE BALLOON HSG CATHETER WITH CLOSED END AND SIDEPORT
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key14235907
MDR Text Key290274013
Report Number14235907
Device Sequence Number1
Product Code LKF
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG17471
Device Catalogue NumberJ-CHSG-703001
Device Lot Number13602695
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2022
Event Location Hospital
Date Report to Manufacturer04/28/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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