MAUDE Adverse Event Report: Caldera Medical, Inc. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Abnormal Vaginal Discharge (2123); Urinary Incontinence (4572)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a gynecare tvt implant procedure and had a favorable outcome of spontaneous urination without difficulty or recurrence of incontinence.However, for a few months, the patient experienced the reappearance of a more marked emergency, associated with malodorous vaginal discharge.Endoscopic exploration was therefore programmed to eliminate erosion of the strip.In (b)(6) 2022, the patient had a clinical examination and the presence of anterior vaginal erosion, facing the urethra measuring approximately 1 cm wide by 4 mm high, with a strip that was visible.In (b)(6) 2025, the patient had a cystoscopy and vaginoscopy.It was found that the patient had an absence of involvement of urethra and bladder and an absence of other areas of erosion or associated abnormality.It was decided to proceed to an excision of the exposed strip fragment, associated with vaginal covering.The patient was informed of the risk of recurrence of urinary incontinence following this procedure.It was also noted that the patient has multiple sclerosis and is currently taking ocrevus.In addition, the patient is autonomous in walking, has a known neuro-bladder, and mixed urinary incontinence with also some imperiosities in the context of her neurovessie.
Additional Manufacturer Narrative
The neuchatel team received one gynecare tvt device 810041bl, lot number: 3935674 (part of mesh) for device analysis.An investigation was performed on the received product and on the batch record file.The received device was manipulated and explanted as original packaging and all components were missing.Only the remaining part of the mesh was visible with lot of organic matter around it.Based on the evaluation, this complaint is not related to a manufacturing problem.The defect observed during the evaluation corresponds to the description of the event (vaginal erosion) and cannot be confirmed with the received product.The product was conforming to specifications at the release.A manufacturing record evaluation was performed for the finished lot number 3935674 (product code 810041bl) and no non-conformances or manufacturing irregularities were identified.Expiration date: 31oct2022 manufacturing date: 26nov2019.

• Brand Name: GYNECARE TVT
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): Caldera Medical, Inc.; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer (Section G): Caldera Medical Sarl; puits-godet 20; neuchatel, swz 2000 ; SZ 2000
• Manufacturer Contact: ryan curran ; 4360 park terrace dr; suite 140; westlake village, CA 91361 ; +1(818)879-6555
• MDR Report Key: 50855761
• Report Number: 3003990090-2026-02115
• Device Sequence Number: 13136023
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: 810041BL
• Device Lot Number: 3935674
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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: Required Intervention
• Patient Sex: Unknown