WHISPERJECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc.

Event Text Entries

[183689188] Pt stated had issue with whisperject that caused medication to cause a very painful large red welp at injection site where "it looked like it busted open in the middle".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093706
MDR Report Key9824496
Date Received2020-03-11
Date of Report2020-03-09
Date of Event2020-03-09
Date Added to Maude2020-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameWHISPERJECT
Generic NameINTRODUCER, SYRINGE NEEDLE
Product CodeKZH
Date Received2020-03-11
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMYLAN PHARMACEUTICALS, INC

Device Sequence Number: 101

Brand NameGLATIRAMER 40MG PFS INJ (12/BOX)
Product Code---
Date Received2020-03-11
Device Sequence No101
Device Event Key0
ManufacturerMYLAN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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