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

Model Number	810081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pelvic Pain (4865)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the lot number associated with the reported event was not identified.Without a lot number, a review of device history records or production-specific data could not be conducted, thereby limiting the ability to perform a thorough root cause investigation.A review of general manufacturing records indicates that all products released during the relevant timeframe were manufactured in accordance with approved procedures and met established specifications during the manufacturing and quality release process.No deviations or nonconformances related to the described issue were documented.The manufacturing number is (b)(4).
Event or Problem Description
A complaint was received from a dutch woman regarding the tvt-o sling mesh and two prolene polypropylene meshes.This complaint pertains to the tvt-o device from calder medical, while the other device is documented in the ethicon complaint system under reference number (b)(4).The patient had the tvt-o sling mesh (lot number unknown) implanted on (b)(6) 2014.She experienced several symptoms, including vaginal pain, pelvic pain, pain during intercourse, groin pain, leg pain, arm pain, variably elevated creatine kinase (ck) levels, and fatigue.Due to these ongoing issues, the surgeon removed the tvt-o vaginal sling and the remnants of the posterior rectopexy mesh on (b)(6) 2025.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Common Device Name: TVT-CAL-OBTURATOR
• 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: 23427479
• Report Number: 3003990090-2025-01691
• Device Sequence Number: 18187419
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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): 10/30/2025

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
• Device Model Number: 810081
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• 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