Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD NITI-S PYLORIC AND DUODENAL UNCOVERED STENT; PYLORIC AND DUODENAL STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TAEWOONG MEDICAL CO., LTD NITI-S PYLORIC AND DUODENAL UNCOVERED STENT; PYLORIC AND DUODENAL STENT Back to Search Results
Model Number DDT2212
Device Problems Break (1069); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, pt received duodenal implantation.Two stents are implanted within a procedure, one at anal side and another to slightly overlap the first.On (b)(6) 2014, stent fracture admitted.Removal of fractured part is not possible.The pt is kept under periodic follow up.Physician attributes fracture to peristaltic movement especially because the stent on anal side got fractured.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NITI-S PYLORIC AND DUODENAL UNCOVERED STENT
Type of Device
PYLORIC AND DUODENAL 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 Key4495606
MDR Text Key5333651
Report Number3003902943-2014-00027
Device Sequence Number1
Product Code MUM
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 12/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2017
Device Model NumberDDT2212
Device Catalogue NumberTW-TC-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/03/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-