FDA.reportPublic FDA data

MAUDE MDR 7038882

MDR report key
7038882
Report number
1000526113-2017-70001
Event key
0
Event type
3
Date received
2017-11-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NUVAGENNUVAGENBELCHER PHARMACEUTICALS, LLCKOZ* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-160

Event Narratives#

D

Patient 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]