MAUDE Adverse Event Report: Caldera Medical, Inc. Desara One; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number	CAL-DS2111
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Desara One
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): Caldera Medical, Inc.; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer (Section G): Caldera Medical Inc.; 4360 park terrace dr; suite 140; westlake village CA 91361
• Manufacturer Contact: ryan curran ; 4360 park terrace dr; suite 140; westlake village, CA 91361 ; +1(818)879-6555
• MDR Report Key: 50941278
• Report Number: 3003990090-2026-02116
• Device Sequence Number: 21514049
• Product Code: PAH
• UDI-Device Identifier: 00890594000957
• UDI-Public: 00890594000957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: CAL-DS2111
• Device Lot Number: S01010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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