MAUDE Adverse Event Report: CALDERA MEDICAL, INC DESARA BLUE SS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR SUI

Model Number	CAL-DS01BS
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During placement of a desara blue short suture sling (cal-ds01bs, lot q08025), the suture broke intraoperatively.The surgeon placed a second sling to complete the procedure.No patient injury resulted.Reported by (b)(6) on (b)(6) 2026, originating from dr.(b)(6), (b)(6) medical center, (b)(6).Replacement requested; return of failed device (lot q08025) for evaluation to be requested.Investigation ongoing.

• Brand Name: DESARA BLUE SS
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR SUI
• 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 drive; suite 140; westlake village CA 91361
• Manufacturer Contact: ryan curran ; 4360 park terrace dr.; suite 140; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 25324484
• Report Number: 3003990090-2026-02077
• Device Sequence Number: 21316815
• Product Code: OTN
• UDI-Device Identifier: 00890594000735
• UDI-Public: 00890594000735
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/28/2026

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-DS01BS
• Device Catalogue Number: CAL-DS01BS
• Device Lot Number: Q08025
• 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: 05/19/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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: Female