WHISPERJECT DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for WHISPERJECT DEVICE manufactured by Mylan Pharmaceuticals, Inc..

Event Text Entries

[178348635] Patient? S daughter reports that the whisperject device is not working properly. She said the orange button will not move. Provided phone # to mylan for troubleshooting and possible replacement if defective.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092832
MDR Report Key9681841
Date Received2020-02-06
Date of Report2020-02-01
Date of Event2020-02-01
Date Added to Maude2020-02-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
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 DEVICE
Generic NameINTRODUCER, SYRINGE NEEDLE
Product CodeKZH
Date Received2020-02-06
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMYLAN PHARMACEUTICALS, INC.

Device Sequence Number: 101

Product Code---
Date Received2020-02-06
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.