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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that clinical trial patient (b)(6) experienced vaginal tape erosion, with a probable relationship to the study device.
Additional Manufacturer Narrative
An analysis of the product could not be conducted because a physical sample was not received for evaluation.Additionally, the evaluation of the manufacturing documentation was incomplete as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed in accordance with approved specifications.Monitoring of additional complaint information for potential safety signals will be carried out through complaint trending as part of post-market surveillance.If the product or further information is received later, the investigation will be updated as necessary.The manufacturing number is (b)(4).

• Brand Name: TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
• Common Device Name: TVT-CAL-ABBREVO
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• 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, CA 91361
• MDR Report Key: 23375387
• Report Number: 3003990090-2025-01666
• Device Sequence Number: 8870131
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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
• 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: 07/25/2025
• Initial Report FDA Received Date: 10/23/2025
• 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