MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT OBTURATOR W LASR; TVT-CAL-RETROPUBIC

Catalog Number	810081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Retention (2119); Urinary Tract Infection (2120); Pelvic Pain (4865)
Date of Event	08/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported when available.The manufacturing complaint's number is (b)(4).
Event or Problem Description
Dir 129257 received from tga in relation to gynecare tvt system - transobturator tape (mesh) - prosthesis, incontinence product details provided: 810081 part number: 810081 lot number: 3238455 date of implantation: (b)(6) 2009 date of explanation: (b)(6) 2025 on the (b)(6) 2025 patient went for insertion of tvto + cystoscopy + posterior vaginal wall repair + refashioning of left minora.Post procedure patient experienced slow urine flow and from approximately 2021 she noted there were feelings of incomplete emptying.Patient was also experiencing progressive pain on coitus with bleeding leading to no coitus for past 2 years.Patient also experienced some groin pain.Patient was also suffering with recurrent utis and required cefalex prophylaxis.In (b)(6) 2024, patient had an examination under anesthesia, which demonstrated a urethral erosion with stone building into a diverticulum.This resulted in the patient requiring surgery and on the (b)(6) 2025 patient had a complete removal of transobturator sling, urethral reconstruction and cystoscopy.Post operatively from tvto removal patient had fevers likely due to infection/colonisation of tvto and left femoral nerve neuropraxia secondary to inflammation adjacent to left gracilis with weakness in left hip adduction and flexion which has now significantly improved.Patient history: ht; gord; t2dm; high chol patient outcome/consequences: n/a disclaimer no further information available as reporter details have not been disclosed (confidential).".
Additional Manufacturer Narrative
Additional information: d4, 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 3238455 (product code 810081l), and no non-conformances / manufacturing irregularities were identified.Expiration date: 31.Oct.2009 manufacturing date : 19.Nov.2008" 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 OBTURATOR W LASR
• Common Device Name: TVT-CAL-RETROPUBIC
• 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: 24075539
• Report Number: 3003990090-2026-02007
• Device Sequence Number: 10226901
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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 Expiration Date: 10/31/2009
• Device Catalogue Number: 810081L
• Device Lot Number: 3238455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2008
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female