MAUDE Adverse Event Report: CALDERA MEDICAL INC. TVT W/ABDOMINAL GUIDES 1 PACK; TVT-CAL-ABDOMINAL

Catalog Number	810041A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dir (b)(4) (tga report) concerns an ethicon gynecare tvt retropubic system (product 810041a) implanted on (b)(6) 2015.Post-implantation, the patient experienced worsened urinary incontinence, unresolved stress incontinence, overactive bladder, constant urine leakage (requiring pads), nocturia 2¿3 times, slow urinary stream, and voiding difficulties.Urodynamics (b)(6) 2023) showed detrusor overactivity with possible bladder outlet obstruction (boo).An examination under anaesthesia with pop-q and cystourethroscopy on (b)(6) 2025 found a healthy vagina/cervix, no mesh exposure, normal urothelium, and clear urethroscopy.The patient has been consented for excision of the vaginal tvt mesh portion + cystoscopy to relieve urethral tension causing slow voids and overflow leakage and has waited >12 months for the procedure.No further patient outcome details are provided due to confidentiality.
Additional Manufacturer Narrative
Investigation is pending and results will be reported when it is available.The manufacture complaint's number is (b)(4).
Additional Manufacturer Narrative
Correction: d1; d2a, d4.
Additional Manufacturer Narrative
Additional information: a3a, h6, h11 investigation results: "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 manufacturing number is (b)(4).

• Brand Name: TVT W/ABDOMINAL GUIDES 1 PACK
• Common Device Name: TVT-CAL-ABDOMINAL
• 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: 24072518
• Report Number: 3003990090-2026-02006
• Device Sequence Number: 15799675
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (Y/N): N
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,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 Catalogue Number: 810041A
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 01/15/2026; 02/23/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/15/2026; 03/04/2026
• 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: Required Intervention
• Patient Sex: Female