MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA ONE; MESH

Catalog Number	DS2113
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation because it had been implanted.A review of the device history records found no nonconformances, and all devices met the acceptance criteria and specifications before their release.The details of the complaint do not clarify whether the reported event is related to the device itself, the surgical technique, or the experience of the surgeon.Unfortunately, no additional information could be obtained from the user.This report consider as part of capa ca25-512.The manufacturing number is (b)(4).
Event or Problem Description
According to the rn, one side of the sling was broken and unusable.There was no injury to the patient, and a second device was opened and used.

• Brand Name: DESARA ONE
• Common Device Name: MESH
• 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: 23419975
• Report Number: 3003990090-2025-01591
• Device Sequence Number: 16060307
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191416
• 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): 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: DS2113
• Device Lot Number: Q08038
• 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: 03/27/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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