FDA.reportPublic FDA data

MAUDE MDR 9659260

MDR report key
9659260
Report number
MW5092702
Event key
0
Event type
3
Date received
2020-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1AUTOJECTINTRODUCER, SYRINGE NEEDLEOWEN MUMFORD, LTD.KZH Y
101COPAXONE 40MG/ML---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-310

Event Narratives#

D

Patient 1

WHO GAVE YOU INFO? PT. WHAT IS THE COMPLAINT ABOUT THE PRODUCT? AUTOJECT IS GETTING SLOW, NOT ALWAYS INJECTING COMPLETELY. WAS THE PRODUCT TAKEN OR ADMINISTERED? YES, SOMETIME. WHAT IS THE LOT NUMBER? UNK. CAN THE MFR CALL THE F/U IF NECESSARY? YES. CAN THE MFR ARRANGE FOR PRODUCT PICKUP? YES. MD AWARE AND DRUG THERAPY CONTINUES UNCHANGED. UNK IF PT EXPERIENCE ANY SIDE EFFECTS DUE TO DOSE NOT COMING OUT FULLY. REPORTED TO (B)(6) BY PT/CAREGIVER.