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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VALERITAS, INC. V-GO DISPOSABLE INSULIN DELIVERY DEVICE

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VALERITAS, INC. V-GO DISPOSABLE INSULIN DELIVERY DEVICE Back to Search Results
Model Number V-GO 20
Device Problem Appropriate Term/Code Not Available
Event Date 05/01/2019
Event Type  Malfunction  
Event Description

Patient informed that one day he experienced the needle button popping out before 24 hours. Patient stated that he does not remember the exact date this occurred.

 
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Brand NameV-GO DISPOSABLE INSULIN DELIVERY DEVICE
Type of DeviceV-GO
Manufacturer (Section D)
VALERITAS, INC.
293 boston post road west
suite 330
marlborough MA 01752
Manufacturer (Section G)
VALERITAS, INC.
293 boston post road west
suite 330
marlborough MA 01752
Manufacturer Contact
scott huie
293 boston post road west
suite 330
marlborough , MA 01752
9089279920
MDR Report Key8746923
Report Number1226572-2019-00123
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberV-GO 20
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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