MAUDE Adverse Event Report: CALDERA MEDICAL INC. TVT EXACT RETROPUBIC SYSTEM; TVT-CAL-EXACT

Model Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical trial patient (b)(6) experience, residual urine.Relationship to study device: not related.
Additional Manufacturer Narrative
The investigation is ongoing and the result will be reported when it is available.The internal complaints number is (b)(4).
Additional Manufacturer Narrative
Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation."a manufacturing record evaluation was performed for the finished device lot number 3945031 (product code tvtrl), nr-0260750 was found for the finish good and nr-0257578 was found for the sub-assembly (product code p25244, lot number 3945008).Nr reviewer has reviewed the nr file and has concluded, based on the information available in the nr file, that nr-0260750 and nr-0257578 are not related to the reported complaint condition or identified malfunction.Expiration date : 31.May.2026 manufacturing date : 17.Jun.2025" 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 manufacturing number is (b)(4).
Additional Manufacturer Narrative
Correction: g1.The manufacturing number is (b)(4).

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA
• Manufacturer (Section G): CALDER MEDICAL; sarl-nauchatel; puits-godet 20; neuchatel 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; puits-godet 20; suite 140; neuchatel, 2000 ; WZ 2000
• MDR Report Key: 24185097
• Report Number: 3003990090-2026-02014
• Device Sequence Number: 9524411
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 05/31/2026
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3945031
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 03/10/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/10/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female