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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD COOK TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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COOK IRELAND LTD COOK TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Model Number G22181
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
During colonoscopy and insertion of fecal decompression device when withdrawal of inner black stylet of decompression tube, the stylet broke leaving some of the stylet in place. Physician determined it would be left in place as device would still function and there would be no harm to patient.
 
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Brand NameCOOK
Type of DeviceTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
COOK IRELAND LTD
750 daniels way
bloomington IN 47404
MDR Report Key12982904
MDR Text Key282121130
Report Number12982904
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22181
Device Catalogue NumberCDSG-14-175
Device Lot NumberC18358621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2021
Date Report to Manufacturer12/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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