MAUDE Adverse Event Report: MANNKIND CORPORATION - V-GO V-GO 20; V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number V-GO 20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/07/2023

Event Type  Injury  

Manufacturer Narrative

Adverse event (ae) assessment: a patient with type 2 diabetes using v-go 20 for more than 5 years reported to ae assessor that she has developed a red itchy rash at v-go sites where the adhesive was placed on her skin.The rash lasts about a week.Her hcp prescribed cortisone cream which has reduced the redness and itchiness.The vgo adhesive is medical grade and hypoallergenic, but some patients may still have a reaction.The patient is using a brush to get the excess adhesive off her skin which may be contributing to her skin sensitivity.Explained how to apply the cavilon barrier wipes.She said both her primary care provider (pcp) and her diabetes healthcare practitioner (hcp) are aware of the problem.

Event Description

The patient reported that her skin gets red and irritated where the vgo adhesive is in which required her healthcare practitioner (hpc) to prescribe cortisone cream.There is no device available for return to the manufacturer for evaluation.

• Brand Name: V-GO 20
• Type of Device: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Manufacturer (Section D): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer (Section G): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer Contact: jeffrey zajac ; 293 boston post road w; #330; marlborough, MA 01752
• MDR Report Key: 16825218
• MDR Text Key: 314112464
• Report Number: 1226572-2023-00035
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female