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

Model Number	CAL-DS01BS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Caldera was notified that trihealth (bethesda north hospital) reported an issue with a desara blue ss sling, lot r06068.Additional information received on (b)(6) 2026 indicated that, when the surgeon was putting the trocar into the loop, the loop stitching broke.No patient injury, procedure impact, device return status, serial number, udi, implant information, treatment, or patient outcome was provided at the time of this report.The facility requested a replacement product.Additional information is being requested.

• Brand Name: DESARA BLUE SS
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, SUI, RETROPUBIC OR
• 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 drive; suite 140; westlake village, CA 91361
• MDR Report Key: 25402521
• Report Number: 3003990090-2026-02079
• Device Sequence Number: 6015061
• Product Code: OTN
• UDI-Device Identifier: 00890594000735
• UDI-Public: 00890594000735
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: CAL-DS01BS
• Device Catalogue Number: CAL-DS01BS
• Device Lot Number: R06068
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/04/2026
• 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: Female