RESONANCE STENT SET

Report

• Report Number: 3005580113-2021-00098
• Event Type: Injury
• Date Received: September 2, 2021
• Report Date: September 2, 2021
• Manufacturer: COOK IRELAND LTD
• Product Code: FAD
• Adverse Event: Yes
• Report Source: Distributor report
• Reporter Location: NC, US
• Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

COMMON DEVICE NAME: FAD STENT, URETERAL.

Description of Event or Problem · 1

ACCORDING TO THE INITIAL REPORTER, PATIENT "DEVELOPED A URETERO-ARTERIAL FISTULA AND REQUIRED A NEPHROSTOMY TUBE AND THE STENT REMOVED."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1315361	RESONANCE STENT SET		FAD	COOK IRELAND LTD		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention

Terms

Patient problem · 1

• Fistula

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission