MAUDE Adverse Event Report: CALDERA MEDICAL INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; TVT-CAL-EXACT

Catalog 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	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical trial patient esc_2020_03: (b)(6) experience, post operative urinary retention.Relationship to study device: unlikely.Surgocal intervention performed on (b)(6) 2026.
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported as soon as they are available.The internal complaint's manufacture number is (b)(4).

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr,; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL- ETHICON SARL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• MDR Report Key: 25000859
• Report Number: 3003990090-2026-02064
• Device Sequence Number: 15638743
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 04/27/2026
• Initial Report FDA Received Date: 04/27/2026
• 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: 46 YR
• Patient Sex: Female