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

Model Number	V-GO 30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient reported he had 3 devices fall off after he took a shower.No additional information was provided.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): MANNKIND CORPORATION - V-GO; 1 casper street; danbury CT 06810
• Manufacturer (Section G): MANNKIND CORPORATION - V-GO; 1 casper street; danbury CT 06810
• Manufacturer Contact: james foley ; 1 casper street; danbury, CT 06810
• MDR Report Key: 25347767
• Report Number: 1226572-2026-00004
• Device Sequence Number: 21443735
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)271024(10)FG325012
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V-GO 30
• Device Lot Number: FG325012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Male