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

Model Number	810081L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Pelvic Pain (4865); Bladder Dysfunction (4881)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the device is not retuned.Based on the limited information provided, the reported product complaint could not be confirmed.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.
Event or Problem Description
"patient underwent 3 operations for hysterectomy, cystocele and strip date#1 by a gynecologist who gave me no information, no contraindications, no booklet or explanation! he decided to put this strip on me without me needing it.Current condition of the patient: mutilated, with severe postoperative complications, multiple surgeries, months of hospitalization, and rehabilitation at a specialized center.To date, i am officially recognized as disabled by mdph and cpam.I suffer from dysuria, bladder hyperactivity, and can no longer urinate seated (it does not come out); i have to urinate standing.I can no longer walk, and i experience daily pain.I have a priority card and a parking card.I can no longer work except remotely.I am currently losing my job because it is impossible to work full-time remotely.".
Additional Manufacturer Narrative
Additional information: a3, d5,e, e3, g4, h6, h11.Correction: b2, b3.Investigation results: an analysis of the product could not be conducted because a physical sample was not received for evaluation.However, we performed an evaluation of the manufacturing records for the finished device lot number and found no non-conformances or manufacturing irregularities.As part of quality process, all devices are manufactured, inspected, and distributed according to approved specifications.Additionally, we will continue to monitor complaint information for potential safety signals through complaint trending as part of our post-market surveillance.If the product is received at a later date, we will update the investigation as necessary.The manufacturing number is (b)(4).

• Brand Name: TVT-CAL-OBTURATOR
• Common Device Name: GYNECARE TVT OBTURATOR W LASR
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr.; suite 140; westlake village 91361
• Manufacturer (Section G): ETHICAN SARL-NEUCHATEL; puits-godet 20; neuchatel 2000, ; WZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23092529
• Report Number: 3003990090-2025-01615
• Device Sequence Number: 18562254
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/24/2025

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 Model Number: 810081L
• Device Lot Number: 3936240
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other; Hospitalization
• Patient Sex: Female