MAUDE Adverse Event Report: CALDERA MEDICAL TVT-CAL-EXACT

Catalog Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported when available.The manufacturing number is (b)(4).
Event or Problem Description
It was reported via clinical trial patient (b)(6) experience, er visit for uti symptoms.Relationship to study device: unlikely.
Additional Manufacturer Narrative
Correction: g1 and h11 (the internal complaint number is (b)(4), while it was reported (b)(4).
Additional Manufacturer Narrative
Additional information: h6, h11 investigation results: 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.

• Brand Name: TVT-CAL-EXACT
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• Manufacturer (Section G): CALDERA MEDICAL SARL NAUCHTEL; 43puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 24507051
• Report Number: 3003990090-2026-02042
• Device Sequence Number: 16062361
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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 Catalogue Number: TVTRL
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 04/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/10/2026; 04/23/2026
• 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 Age: 62 YR
• Patient Sex: Female