MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT RETROPUBIC DEVICE; TVT-CAL-RETROPUBIC

Model Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Frequency / Polyuria (2275); Urinary Incontinence (4572); Interstitial Cystitis (4862)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient, who had a history of urinary incontinence dating back to 2016, experienced a recurrence of stress urinary incontinence.To address this, she received a tension-free vaginal tape (tvt) strip (ref.810041bl; lot 3822871; johnson & johnson).Unfortunately, after an early failure, she experienced a return of incontinence following a coughing episode related to pertussis.As a result, a second tvt strip was placed, and a rectocele repair was performed through the vaginal route in (b)(6) 2017.
Additional Manufacturer Narrative
The product was not returned.The investigation is ongoing and the results of investigation will be reported.This complaint is related is related to complaint (b)(4).This report is related to report 3003990090-2025-01683.The manufacturing number is (b)(4).
Additional Manufacturer Narrative
Additional information: d4; d5; h4; h6; h11.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 lot number 3822871 (product code 810041bl), and no non-conformances / manufacturing irregularities were identified.Expiration date: 31.Dec.2017 manufacturing date: 13.Jan.2015" 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: GYNECARE TVT RETROPUBIC DEVICE
• Common Device Name: TVT-CAL-RETROPUBIC
• 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: 23398868
• Report Number: 3003990090-2025-01682
• Device Sequence Number: 18686994
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• 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): 12/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 810041BL
• Device Lot Number: 3822871
• 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: 10/04/2025
• Supplement Date Received by Manufacturer: 12/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2015
• 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