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

Model Number	810081L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury

• 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 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: 50955036
• Report Number: 3003990090-2026-02119
• Device Sequence Number: 15827461
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 810081L
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• 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: Required Intervention
• Patient Sex: Unknown