FDA Adverse Event Malfunction Summary report: N

NUVAGEN

MDR report key: 7029116 · Received November 14, 2017

Report

Report Number
1000526113-2017-00001
Event Type
Malfunction
Date Received
November 14, 2017
Date of Event
November 2, 2017
Report Date
November 3, 2017
Manufacturer
BELCHER PHARMACEUTICALS,LLC
Product Code
KOZ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

PATIENT RECOVERED.

Description of Event or Problem · 1

PATIENT HAS EXPERIENCE WITH HEADACHE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
806708 NUVAGEN NUVAGEN COLLAGEN POWDER KOZ BELCHER PHARMACEUTICALS,LLC 9066385 123456

Patients

Seq Age Sex Outcome Treatment
1 40 YR Other