MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE TVEZ 3.0 SYSTEM; INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE

Catalog Number	CAL-DS01BTV30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperplasia (1906); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Discoloration (2074); Unspecified Nervous System Problem (4426); Sexual Dysfunction (4510); Swelling/ Edema (4577)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The fda (food and drug administration) sent a medical device report under mw5162638.Pt history of renal congenital defects.Told mus was safe and gold standard.Surgeon recommended mus after pop repair, stating urethra was "kinked" and would need support after pop (pelvic organ prolapse) repair.Pt had thin vag tissues.Surgeon placed mus a little differently (per surgeon).Pt complained in post-op recovery of unusual severe pain, swelling, clots, bleeding, and severe urethral swelling.Pt dismissed and told all normal.Pt reported severe tissue and nerve pain, clinical swelling, mesh palpable w/ internal exam, inability to sit, for months following mus and pop sx.Pt advocated for help complaining of cont.Post surgical pain, inability to sit, urethral/clitoral pain.Pt dismissed.Pt outsourced to another state for medical care, and to have mesh removed.Pt allergic to mesh and had dx mesh complications.Pt suffered severe pain, swelling, hyperplasia, nerve pain, clinical swelling and redness.Pt developed severe internal bleeding during mesh removal sx.Pt needed re-hospitalization for blood transfusion from mesh removal.Pt suffers with scar tissue and adhesions from mesh and mesh removal.Pt unable to have sex.Pt needing cont.Pfpt (pelvic floor physical therapy) and medical care for injuries related to mesh complications.Too many women are dismissed and treated disrespectfully when returning back to their medical providers complaining of pain after mus sx.This is not acceptable.These reactions, reported symptoms, and clinical symptoms need to be taken seriously.This had adversely affected my body and my life, with loss of my sexual function, with cont.Daily pain.Fibrin (b)(6).
Additional Manufacturer Narrative
An investigation could not be conducted thoroughly because the device was not returned.A review of general manufacturing records indicates that all products released during the relevant timeframe were made in accordance with approved procedures and met the established specifications during the manufacturing and quality release process.However, according to the complaint information, the patient reported an allergy to mesh and unsuccessful surgical procedures.As a result, the cause was attributed to non-device-related factors.Based on the available information, no further action is required at this time.If additional information becomes available, the investigation will be updated as necessary.This report consider as part of capa: ca25-512.The manufacturing number is (b)(4).

• Brand Name: DESARA BLUE TVEZ 3.0 SYSTEM
• Common Device Name: INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, 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: 23416527
• Report Number: 3003990090-2025-01586
• Device Sequence Number: 21078531
• Product Code: PWJ
• UDI-Device Identifier: 00890594000087
• UDI-Public: 00890594000087
• Combination Product (Y/N): N
• PMA/510(K) Number: K211975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CAL-DS01BTV30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White