MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT RETROPUBIC DEVICE; TVT-CAL-RETROPUBIC

Model Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Frequency / Polyuria (2275); Urinary Incontinence (4572); Interstitial Cystitis (4862)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a tension-free vaginal tape (tvt) procedure in (b)(6) 2017.Since (b)(6) 2019, she has been experiencing pelvic pain, low back pain, and recurrent cystitis, averaging one episode per month.She has been managing her symptoms with self-medication using monuril® or selexid® alternately, without prior urine culture (ecbu).The patient reports symptoms of pollakiuria and urinary incontinence, which have necessitated the use of daily protective wear.Notably, she experiences the "key-in-the-door" syndrome but does not have stress incontinence.A gynecological examination reveals good vulvar health, but there is pain upon palpation of both the anterior and posterior strips of the promontofixation, more pronounced in the posterior strip, without any signs of vaginal erosion.She is also receiving gynecological care due to a recurrence of lesions related to papillomavirus, and a control smear is pending.Cystoscopy revealed healthy, non-inflammatory bladder mucosa with no erosions on the anterior strip or the tvt.There were no stones or polyps, and both the ureters and urethra appeared healthy, though the urethra exhibited slight inflammation.The patient experienced painful bladder filling at 200 cc, with no leakage during coughing.There were no signs of cystocele or rectocele.A rectal examination showed low anal tone.The decision has been made to proceed with the complete removal of the tvt material on (b)(6) 2025.
Additional Manufacturer Narrative
The product was not returned.The investigation is ongoing and the results of investigation will be reported.This complaint is related is related to complaint (b)(4).This report is related to report 3003990090-2025-01683 the manufacturing number is (b)(4).
Additional Manufacturer Narrative
Additional information: d4; h6; h11.Correction: b7.Investigation results: an analysis of the product couldn't be performed since a physical sample wasn't received for evaluation.A manufacturing record evaluation was done for the finished product (product code 810041bl), and no non-conformances or manufacturing irregularities were identified.As part of our company's quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the available info, there's no indication that a design or manufacturing issue caused the reported complaint.Therefore, it's been determined that no corrective and preventive action is required at this time.We'll keep monitoring complaint info for potential safety signals through complaint trending as part of post-market surveillance.If the product is received later, we'll update the investigation as needed.The manufacturing number is (b)(4).

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• Common Device Name: TVT-CAL-RETROPUBIC
• 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: 23399054
• Report Number: 3003990090-2025-01683
• Device Sequence Number: 21344059
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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): 12/29/2025

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: 810041BL
• Device Lot Number: 3915657
• 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: 10/04/2025
• Supplement Date Received by Manufacturer: 12/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2015
• 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