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

Model Number	810081L
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Fistula (1862); Hyperthermia (1909); Fluid Discharge (2686); Urinary Incontinence (4572)
Date of Event	09/13/2017
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 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: 50811743
• Report Number: 3003990090-2026-02113
• Device Sequence Number: 13409313
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Device Lot Number: 3568747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/17/2026
• 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