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

Model Number	V-GO 20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: a patient with type 1 diabetes using v-go for 7-8 months reported to customer care (cc) when he puts on the v-go the skin under the adhesive starts to itch.Once removed the patient sees redness and raised skin.Ae assessor spoke with the patient who confirmed the information from cc (and said he has welts which are likely the raised skin).His medical history indicates he has no allergies, the first several months using the v-go the patient had no skin irritation from the adhesive, and he uses his abdomen and leg for v-go sites.His hcp prescribed cortisone cream which improved the itch a little.He is in contact with someone from his hcp office that has provided cavilon barrier wipes and requested he try nasal spray with antihistamine.Nothing has worked to prevent the itching when the v-go adhesive is applied to the skin, the skin redness and raised skin.The patient said he plans to return to taking insulin injections because the redness at the previous sites takes a week or more to diminish.Ae assessor strongly encouraged him to contact his hcp for medical advisement.
Event or Problem Description
The patient reported that their skin underneath the adhesive pad is itching.Once removed, the patient can see redness and raised skin.The patient reported that his healthcare practitioner (hcp) prescribed some cream, but the patient could still see the irritated skin after days to weeks.No device was available for return to the manufacturer for evaluation.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• 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: 18428682
• Report Number: 1226572-2023-00140
• Device Sequence Number: 20776390
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)FG223059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2026
• Device Model Number: V-GO 20
• Device Lot Number: VG223022C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male