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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S PORGES COLOPLAST STENOSTENT; STENT, URETERAL
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COLOPLAST A/S PORGES COLOPLAST STENOSTENT; STENT, URETERAL Back to Search Results
Model Number AJ4W84
Device Problem Expiration Date Error (2528)
Patient Problem No Information (3190)
Event Date 08/12/2018
Event Type  malfunction  
Event Description
Patient was here for a cystoscopy, right retrograde pyelogram, right ureteral stent exchange.The surgeon chose the stent he wanted; he opened the box, handed stent to an un-scrubbed certified surgical technologist (cst), and said open this.So it was opened on the field and placed in the right ureter.The circulating rn needed product info and when provided this, discovered the stent had expired.Resident notified; he called attending and the decision was made to exchange the stent.The issue is that the box of the stent had an expiration date on it of 5/2018; the package read expired in 4/2018; and the package inside of the larger package listed an expiration date of 6/2021.
 
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Brand Name
PORGES COLOPLAST STENOSTENT
Type of Device
STENT, URETERAL
Manufacturer (Section D)
COLOPLAST A/S
1601 west river road north
minneapolis MN 55411
MDR Report Key7893251
MDR Text Key120854793
Report Number7893251
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAJ4W84
Device Catalogue NumberAJ4W84
Device Lot Number5236295
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2018
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer09/20/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age13870 DA
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