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 Code	Conjunctival Hemorrhage (4808)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing and the results will be reported when are available.The internal manufacture's complaints number is (b)(4).
Event or Problem Description
It was reported via clinical trial patient (b)(6) experience, intracranial haemorrhage.Relationship to study device: not related.

• 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: 24185768
• Report Number: 3003990090-2026-02018
• Device Sequence Number: 18144974
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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 Model Number: TVTOML
• Device Catalogue Number: TVTOML
• 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
• Initial Report FDA Received Date: 01/26/2026
• 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 Sex: Female