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	Erosion (1750); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Depression (2361)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after the surgery, the patient developed repeated urinary tract infections, which required taking antibiotics almost permanently and caused the patient intestinal problems - pain in the bladder, urine retention, severe fatigue, and a depressive state.
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.Based on the information available, no further action is required at this time.This complaint will be documented and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as necessary.The manufacturing number is (b)(4).
Additional Manufacturer Narrative
Additional information: d5, h6, h11.Correction h6 (component code).Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 (b)(4).

• 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: 23442643
• Report Number: 3003990090-2025-01700
• Device Sequence Number: 12899613
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 810081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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