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

Model Number	TVTRL
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing and the results will be reported when available.The internal complaints number is (b)(4).
Event or Problem Description
Ethicon complaint handling team reported that a tvtrl came in the original package without tape.
Additional Manufacturer Narrative
Correction: b1, g1, h1, h3.Addtional information h6, h11.Neuchatel team received for evaluation one product of gynecare exact product code tvtrl and lot number 5000039.An investigation was performed on received product and on the batch record file.The device received has been manipulated with and the blister packaging is open.The following components are missing: box, ifu and mesh with plastic needles.The seal transfer is visible and flawless, leading to the conclusion that the device packaging was properly sealed and subsequently opened.The identification labels on the lid and blister correspond to the batch.The information is written on the lid of the device by hand with a pen.During the products evaluation, the neuchâtel team observed another defect in the product, white particles in the primary packaging.A measurement of particles sizes has been performed with a tappi chart #ne1685, as follow: all particles measured were less than 0.4 mm² or 3 mm in length but not attributable to the product (mesh or white particle from the mesh generated during the manufacturing), "(b)(4)" in the section notes).Based on the information provided, this claim matches the description of the issue: (original packaging without adhesive tape).The complaint is confirmed and is not related to a manufacturing defect.Based on the information currently available, the white particle issue was identified during the examination of the samples received.This product-related issue will be addressed by ethicon's quality system.The powder has been confirmed to be from the underside of the tyvek adhesive - powder is created during transit when device/packaging is contacting underside of the tyvek material all materials used in these devices and packaging meet the biocompatibility requirements contained in iso 10993-i: "biological evaluation of medical devices - part 1: evaluation and testing" and on fda general program memorandum #g95-i: use of international standard iso - 10993, "biological evaluation of medical devices - part 1: evaluation and testing." the white powder has been tested by a third-party laboratory for potential cytotoxicity concerns.It has been determined that the potential deposition of these particles into the patient would not significantly increase the risk of toxicity.The internal complaint 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 ; 4360 park terrace dr.; suite 140; westlake village
• MDR Report Key: 24202479
• Report Number: 3003990090-2026-02021
• Device Sequence Number: 9855430
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: Health Professional
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 5000039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Female