AUTOJECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for AUTOJECT manufactured by Owen Mumford, Ltd..

Event Text Entries

[177676044] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092702
MDR Report Key9659260
Date Received2020-01-31
Date of Report2020-01-24
Date Added to Maude2020-02-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameAUTOJECT
Generic NameINTRODUCER, SYRINGE NEEDLE
Product CodeKZH
Date Received2020-01-31
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerOWEN MUMFORD, LTD.

Device Sequence Number: 101

Brand NameCOPAXONE 40MG/ML
Product Code---
Date Received2020-01-31
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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