MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2014-08-18 for V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO 40 manufactured by Valeritas, Llc..
[4726007]
It was reported to valeritas customer care that diabetic patient (pt). Type 2 using the v-go 40 since (b)(6) 2014 experienced an abscess on his abdomen while using the v-go. According to the valeritas adverse event (ae) assessor, the patient stated that on (b)(6)2014, he removed the v-go from his left abdominal area, noticed a red mark and after a few days the red mark became "much larger, was hot, hard and very painful to touch". Patient reports he went to the emergency room on (b)(6) 2014, the abscess was drained and packed. Patient was not hospitalized. Patient states the drainage is still continuing (patient was not able to describe drainage amount or color), the site is very red and tender, the size of silver dollar. Patient was given a prescription and instructed to start antibiotics immediately (name of antibiotic unknown by patient), however patient has not filled the antibiotic prescription and states he will not be able to start the antibiotic till (b)(6) 2014 due to financial reasons. Ae assessor instructed patient to contact his hcp right away to discuss with hcp that he has not started the antibiotic. Patient is currently off the v-go for financial reasons, he was not discontinued from v-go by hcp.
Patient Sequence No: 1, Text Type: D, B5
[12179674]
This mdr is being submitted per our procedure. Patient experienced an adverse event in the form of an abscess (on abdomen) at application site. Patient went to the emergency room where the abscess was drained and packed (medical intervention) to prevent further complications. The device was not available for investigation. Even though the v-go is terminally sterilized, there is always the possibility of infection at the application site and site preparation. Diabetics are also prone to infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226572-2014-00008 |
| MDR Report Key | 4036900 |
| Report Source | 04,CONSUMER |
| Date Received | 2014-08-18 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-07-18 |
| Date Mfgr Received | 2014-07-25 |
| Date Added to Maude | 2014-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT HUIE |
| Manufacturer Street | 800 BOSTON TURNPIKE |
| Manufacturer City | SHREWSBURY MA 01545 |
| Manufacturer Country | US |
| Manufacturer Postal | 01545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-GO DISPOSABLE INSULIN DELIVERY DEVICE |
| Generic Name | V-GO |
| Product Code | KZE |
| Date Received | 2014-08-18 |
| Model Number | V-GO 40 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALERITAS, LLC. |
| Manufacturer Address | 750 ROUTE 202 SOUTH SUITE 100 BRIDGEWATER NJ 088072597 US 088072597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-18 |