MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number	810081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Constipation (3274); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a gynecological surgery on (b)(6) 2006 and tvt and gyno-mesh were implanted.It was reported that the patient experienced pain.No additional information was reported.".
Additional Manufacturer Narrative
The investigation is ongoing and the results will be reported when it is available.The internal complaint number is (b)(4).
Additional Manufacturer Narrative
: addtional information g1, h6, h11."an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore, it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable." the internal complaint number is (b)(4).

• Brand Name: GYNECARE TVT
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA
• Manufacturer (Section G): Caldera Medical Sarl; puits-godet 20; 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: 24284767
• Report Number: 3003990090-2026-02027
• Device Sequence Number: 21322806
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: Health Professional
• Device Expiration Date: 05/31/2007
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 2924217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2006
• Supplement Date Received by Manufacturer: 03/19/2026; 08/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/19/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2006
• 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: Female