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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT
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TAEWOONG MEDICAL CO., LTD NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT Back to Search Results
Model Number CDT2208
Device Problems Break (1069); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2014
Event Type  malfunction  
Event Description
On (b)(6) 2013, colonic stent (cdt2208) implanted at splenic flexure from transverse colon toward descending colon.On (b)(6) 2014, stent fractured at 2-3cm from the proximal end.Exact date of fracture is unk, but reviewing follow up ct scan images reveal that stent is getting fractured little by little starting.On (b)(6) 2014, completely fracture was confirmed with some fractured parts admitted in the middle of transverse colon.Cdt2212 was newly implanted stent in stent on the same day.So far, no complication has been reported.
 
Manufacturer Narrative
Fracture might occur from the pt's peristaltic action.For this issue, it is documented in the product's user manual.However, the suspected device is not registered to us fda and it has not been shipped into the us.
 
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Brand Name
NITI-S ENTERAL COLONIC UNCOVERED STENT
Type of Device
COLONIC STENT
Manufacturer (Section D)
TAEWOONG MEDICAL CO., LTD
gimpo-si, gyeonggi-do
KS 
Manufacturer Contact
14, gojeong-ro, wolgot-myeon
gimpo-si, gyeonggi-do 
19960641
MDR Report Key4495608
MDR Text Key5333652
Report Number3003902943-2014-00028
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/18/2016
Device Model NumberCDT2208
Device Catalogue NumberTW-TC-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
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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