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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET
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COOK IRELAND LTD RESONANCE STENT SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Type  Injury  
Event Description
According to the initial reporter: the patient was a female that underwent radiotherapy.The patient had a radiotherapeutic ureteral stricture and was frequently stented until it was decided that they place a resonance stent in her.When the stent stopped working, one physician tried to remove it but couldn¿t.They found out that the resonance stent was outside the collecting system due to a perforation.They decided against performing a radical nephrectomy because of other co-morbidity factors.In agreement with the patient, she was placed in palliative care and the process of assistance in dying, which is legal in (b)(6), was signed and engaged.
 
Manufacturer Narrative
Fad stent, ureteral.
 
Manufacturer Narrative
Common device name) fad stent, ureteral.
 
Event Description
According to the initial reporter: the patient was a female that underwent radiotherapy.The patient had a radiotherapeutic ureteral stricture and was frequently stented until it was decided that they place a resonance stent in her.When the stent stopped working, one physician tried to remove it but couldn¿t.They found out that the resonance stent was outside the collecting system due to a perforation.They decided against performing a radical nephrectomy because of other co-morbidity factors.In agreement with the patient, she was placed in palliative care and the process of assistance in dying, which is legal in (b)(6), was signed and engaged.
 
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Brand Name
RESONANCE STENT SET
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key12923865
MDR Text Key286163667
Report Number3005580113-2021-00146
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Date Report Sent to FDA12/03/2021
Event Location Hospital
Date Report to Manufacturer11/19/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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