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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 Problems Material Disintegration (1177); Difficult to Remove (1528); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 procedure, there was difficulty removing the wire from the catheter.It was noted that part of the wire shredded but was able to be removed with steady gentle traction.Per the initial reporter: "i would assume the catheter tore at that point (not visible externally and the catheter was draining well/operating as expected at the end of the procedure).The catheter was definitely not torn before placing it over the wire".
 
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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 Key6795193
MDR Text Key82947153
Report Number1820334-2017-02565
Device Sequence Number1
Product Code GCA
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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