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

Model Number	TVTOBTUNK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dir 109707 was received from tga regarding the ethicon prosthesis for incontinence.Product details: product: tvto stress urinary incontinence mesh.Date of implantation: on (b)(6) 2011.Date of explanation: on (b)(6) 2025.Clinical event information: the patient underwent a tvt-o procedure for stress incontinence, which involves the insertion of a mid-urethral sling mesh.The patient has a history of chronic classical hodgkin lymphoma (nodular sclerosis) and received treatment consisting of avd (adriamycin, vinblastine, dactinomycin) chemotherapy for four cycles followed by interstitial field radiation therapy (if xrt) with the condition resolved.No further unresolved problems were documented.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information 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: 23379737
• Report Number: 3003990090-2025-01669
• Device Sequence Number: 15671512
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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
• Device Model Number: TVTOBTUNK
• 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: 07/25/2025
• Initial Report FDA Received Date: 10/24/2025
• 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