NUVAGEN

Report

• Report Number: 1000526113-2017-70001
• Event Type: Malfunction
• Date Received: November 16, 2017
• Report Date: November 8, 2017
• Manufacturer: BELCHER PHARMACEUTICALS, LLC
• Product Code: KOZ
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

CASE DESCRIPTION: THIS SPONTANEOUS REPORT FROM A CONSUMER RECEIVED ON 08-NOV-2017 INVOLVED A/AN PATIENT, PATIENT INITIALS DD WHO STARTED TO RECEIVE[SUSPECT_NAMEMOD]. THE PATIENT'S MEDICAL HISTORY WAS NOT AVAILABLE. ON AN UNSPECIFIED DATE THE PATIENT RECEIVED FIRST DOSE OF[SUSPECT_NAMEMOD]:[1] AT ADMINISTERED VIA AN UNSPECIFIED ROUTE AT A DOSE OF FOR AN UNSPECIFIED INDICATION. THE PATIENT DEVELOPED/EXPERIENCED RASH. THE PATIENT'S LABORATORY TEST RESULTS WERE NOT AVAILABLE. (DESCRIBE MEDICATIONS, PROCEDURES, TESTS, INVESTIGATIONS ETC.) FOLLOWING [TREATMENT OR DECHALLENGE/RECHALLENGE]

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
815873	NUVAGEN	NUVAGEN	KOZ	BELCHER PHARMACEUTICALS, LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Rash

Product problems · 1

• Patient-Device Incompatibility

Source type · 1

• CONSUMER

Type of report · 1

• Initial submission