PASSPORT¿

Report

• Report Number: 3005099803-2018-02515
• Event Type: Malfunction
• Date Received: July 30, 2018
• Report Date: July 1, 2018
• Product Code: EZN
• PMA / PMN Number: K941853
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOR THE 2 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012012, 2 COMPLAINT DEVICES WERE RETURNED. 2 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT

Description of Event or Problem · 1

THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2012012 FOR PRODUCT CODE EZN. THIS REPORT COVERS 2 REPORTED EVENTS OF BALLOON PINHOLE. ALL DEMOGRAPHIC INFORMATION IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
572989	PASSPORT¿	DILATOR, CATHETER, URETERAL	EZN		M0062181300

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Burst Container or Vessel

Type of report · 1

• Initial submission