MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE,

Catalog Number	CAL-DS01BSL
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported that a surgeon has observed an increase in mesh erosion cases compared to what he has experienced over the past 15 to 20 years.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.All devices undergo thorough inspection and testing to ensure they meet acceptance criteria before being released.This specific device met all necessary criteria and specifications prior to its release.The details of the complaint seem to reflect the surgeon's preference rather than any malfunction of the device.No device-related issues were reported, and no additional information was obtained from the user.This report consider as part of capa ca25-512.The manufacturing number is (b)(4).

• Brand Name: DESARA BLUE SLING
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE,
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL SARL-NAUCHATEL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 23417281
• Report Number: 3003990090-2025-01588
• Device Sequence Number: 15699084
• Product Code: OTN
• UDI-Device Identifier: 00890594000070
• UDI-Public: 00890594000070
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121928
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Catalogue Number: CAL-DS01BSL
• 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: 02/04/2025
• Initial Report FDA Received Date: 10/29/2025
• 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