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

Catalog Number	CAL-DS2111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mesh erosions can be caused by various factors, including the patient's preexisting conditions or anatomy, surgical techniques such as excessive tension or stretching of the mesh, and the patient's responses, which may include inflammation or infection.Without product lot numbers or product returns, further evaluation of the issue cannot proceed.The complaint does not specify whether the event is related to the product, the surgical technique, the surgeon's experience, or the patient's anatomy.This complaint will be documented and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as necessary.This report is related to report 3003990090-2025-01592, 3003990090-2025-01593, 3003990090-2025-01595 this report consider as part of capa: ca25-512.The manufacturing number is (b)(4).
Event or Problem Description
Per sales rep, erosions are happening at the midline.All patients are post-menopausal, all were prescribed vaginal estrogen.

• 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: 23467252
• Report Number: 3003990090-2025-01594
• Device Sequence Number: 8916060
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CAL-DS2111
• 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: 03/25/2025
• Initial Report FDA Received Date: 11/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female