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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK MULTIPURPOSE DRAINAGE CATHETER 10.2 FR, 25 CM

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WILLIAM COOK MULTIPURPOSE DRAINAGE CATHETER 10.2 FR, 25 CM Back to Search Results
Model Number G09502
Device Problems Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/16/2016
Event Type  malfunction  
Event Description
Patient was being treated for a pelvic abscess. In interventional radiology, the drain in question was placed on (b)(6) 2016. The patient returned to er on (b)(6) 2016 for removal of the drain as her condition had improved. At this time, the er physician attempted removal of the drain and had difficulty. He described that the suture that this drain has along its shaft became "stuck" and despite various attempts/methods to remove it (suture) were unsuccessful. The er physician stated that he has completed many of these procedures and has never had this happen when all or part of the suture is retained in the patient post procedure. The patient was successfully discharged with a course of oral antibiotics.
 
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Brand NameMULTIPURPOSE DRAINAGE CATHETER 10.2 FR, 25 CM
Type of DeviceMULTIPURPOSE DRAINAGE CATHETER
Manufacturer (Section D)
WILLIAM COOK
DA
MDR Report Key5646266
MDR Text Key44999471
Report NumberMW5062187
Device Sequence Number1
Product Code NHC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG09502
Device Catalogue NumberULT10.2-38-25-P-6S-CLM-RH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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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