MAUDE Adverse Event Report: MedSource Labs MedSource; TrueSafe Comfort BC 20G x 1

Model Number	MS-864203
Medical Device Problem Codes	Activation Failure (3270); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction

• Brand Name: MedSource
• Common Device Name: TrueSafe Comfort BC 20G x 1
• Manufacturer (Section D): MedSource Labs; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 50902752
• Report Number: 3003674698-2026-01212
• Device Sequence Number: 16128938
• Product Code: FOZ
• UDI-Device Identifier: 00840155413245
• UDI-Public: 00840155413245
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K223788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: MS-864203
• Device Catalogue Number: MS-864203
• Device Lot Number: 40823/0487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2024
• 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 Sex: Unknown