Brand Name | V-GO DISPOSABLE INSULIN DELIVERY DEVICE |
Type of Device | V-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 Key | 8746923 |
Report Number | 1226572-2019-00123 |
Device Sequence Number | 1 |
Product Code | LZG |
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 Received | 06/30/2019 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Device MODEL Number | V-GO 20 |
Device LOT Number | UNKNOWN |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/22/2019 |
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
|
|
|