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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
Device Problem Appropriate Term/Code Not Available
Event Date 05/21/2019
Event Type  Malfunction  
Event Description

Patient stated that her vgo devices are falling off. Patient stated that she have 11 vgo devices that have fallen off from her skin. Patient stated that last night her vgo device fell off. Patient informed me that the vgo device that she is currently wearing is falling off. Patient stated that the corner of the adhesive pad keep rising up. Patient stated that she is applying the vgo device on her abdomen. Patient stated that she is cleaning the site before applying the vgo device. Patient informed me that she is allowing her skin to dry before applying the vgo device on. Patient stated that she does not remember the exact dates when the other vgo devices fell off. Patient stated that she still have all of the vgo devices available to send back to us.

 
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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 Key8746924
Report Number1226572-2019-00124
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
Device Catalogue Number8560-9400-02
Device LOT NumberVG318220B
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
Date Device Manufactured12/10/2018
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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