MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT-ABBREVO MINI LCM; TVT-CAL-ABBREVO

Model Number	TVTOML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Abnormal Vaginal Discharge (2123); Discomfort (2330); Pelvic Pain (4865)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing and the result will be reported when available.The manufacture internal complaint number is (b)(4).
Event or Problem Description
The patient experienced "medication required; vaginal discharge; inflammation; tissue erosion associated with device; chronic pain; discomfort" after the device was implanted.
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 3944397 (product code tvtoml), and nr-0198675 was found.Nr reviewer has reviewed the nr file and has concluded, based on the information available in the nr file, that nr-0198675 is not related to the reported complaint condition or identified malfunction.Expiration date : 30.Apr.2024 manufacturing date : 24.May.2023" 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 c25-2991.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• Common Device Name: TVT-CAL-ABBREVO
• 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: 24136110
• Report Number: 3003990090-2026-02009
• Device Sequence Number: 18740613
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (Y/N): N
• PMA/510(K) Number: K100936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/04/2026

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: 04/30/2024
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3944397
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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