FDA.reportPublic FDA data

MAUDE MDR 9902658

MDR report key
9902658
Report number
MW5093970
Event key
0
Event type
3
Date of event
2020-03-26
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPIPENINJECTOR, PENMYLAN PHARMACEUTICALS INC.NSCI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. R

Event Narratives#

D

Patient 1

I NOTICED THAT THE BLUE PART OF MY EPIPEN WAS ALREADY RAISED EVEN THOUGH IT HAS NEVER BEEN REMOVED FROM ITS CASE UNTIL TODAY TO CHECK IF IT FELL INTO THE GROUP IN THE EPIPEN FAILURE GROUP. FDA SAFETY REPORT ID# (B)(4).