FDA.reportPublic FDA data

MAUDE MDR 9631975

MDR report key
9631975
Report number
MW5092495
Event key
0
Event type
3
Date of event
2020-01-18
Date received
2020-01-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
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
1WHISPERJECTINTRODUCER, SYRINGE NEEDLEMYLAN PHARMACEUTICALS, INC.KZH N
101GLATIRAMER 40MG PFS INJ (12/BOX).MYLAN---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-240

Event Narratives#

D

Patient 1

PATIENT POTENTIALLY MISSING DOSES DUE TO HER WHISPERJECT NOT WORKING.