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

Model Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cervical Changes (1773); Urinary Tract Infection (2120); Urinary Incontinence (4572)
Date of Event	02/01/2004
Type of Reportable Event	Serious Injury
Event or Problem Description
The 2004 study by ward kl and hilton p aimed to compare the effectiveness of tvt (using the gynecare tvt device) and colposuspension in a randomized, multicenter trial with a 2-year follow-up.Cystocele, cervical prolapse, rectoceles, urodynamic stress incontinence, suprapubic extruation, uti are reported.
Additional Manufacturer Narrative
The product was not returned.Based on the available information, it has been determined that no corrective or preventive action will be proposed 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 manufacture internal complaint number is (b)(4).
Additional Manufacturer Narrative
Correction: g1 addtional information h11 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 internal complaint number is (b)(4).

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA
• Manufacturer (Section G): CALDERA MEDICAL - ETHICON SARL; puits-godet 20; neuchatel, 2000 ; SZ 2000
• Manufacturer Contact: ryan curran ; 4360 park terrace dr.; suite 140; westlake village 91361
• MDR Report Key: 24140328
• Report Number: 3003990090-2026-02012
• Device Sequence Number: 18368364
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3661058
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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: Other
• Patient Sex: Female