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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE SIMP-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
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COOK INC ULTRATHANE SIMP-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER Back to Search Results
Catalog Number ULT8.5-38-25-P-6S-MSL
Device Problem Split (2537)
Patient Problem No Information (3190)
Event Date 07/11/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported during the patient's abscess drainage procedure, it was noted the drain was split down the length of the catheter approximately 2-3" from the pig tail (noticed at approximately the insertion site).It was also reported the drain would not fully unlock and so the drain was removed (using traction) with a partial curl remaining at the distal end.
 
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Brand Name
ULTRATHANE SIMP-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6795132
MDR Text Key82943298
Report Number1820334-2017-02564
Device Sequence Number1
Product Code GBO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberULT8.5-38-25-P-6S-MSL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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