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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD GEENEN PANCREATIC STENT
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COOK IRELAND LTD GEENEN PANCREATIC STENT Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Abscess (1690)
Event Date 12/06/2008
Event Type  Injury  
Manufacturer Narrative
Procode: fge catheter, biliary, diagnostic.
 
Event Description
According to the journal article price et al 2009 (geenen ps) ¿ ¿good stents gone bad: endoscopic treatment of proximally migrated pancreatic duct stents¿.Surgical stents were placed in the pd anastomosis during surgery for the following conditions: pancreatic cancer (6), intraductal papillary mucinous neoplasm (3), and choledochal cyst (1).Surgical stents were standard, small, straight, 3f, geenen stents (cook medical, bloomington, ind).Off-label use (10 patients): surgically altered anatomy and prophylactic use.Liver abscess (1 patient): of the 8 stents within the biliary tree, 1 was complicated by a liver abscess.
 
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Brand Name
GEENEN PANCREATIC STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10599842
MDR Text Key209354124
Report Number3005580113-2020-00418
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 09/28/2020,09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/01/2020
Event Location Hospital
Date Report to Manufacturer09/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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