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

Catalog Number	810081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Urinary Retention (2119); Urinary Tract Infection (2120); Dizziness (2194); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is pending, and the results will be reported when available.The manufacturer internal complaint's number is (b)(4).
Event or Problem Description
Female patient with a 1-year history of pelvic pain, gravity symptoms, and urinary leakage (emergency-type incontinence).Known myxomatous uterus and prolapse (c2h3r2).Clinical history & interventions: pre-operative: manual kinesitherapy (10 sessions) with minimal improvement.Surgery 1 (b)(6) 2021): subtotal hysterectomy with double promontofixation (anterior & posterior banding) and implantation of a microval plate (lot my52910) for prolapse.Post-operative: manual physiotherapy was proposed but not performed due to covid restrictions.Surgery 2 (b)(6) 2022): implantation of an ethicon tvt obturator (tot) sling (lot 3939733) for stage 2 stress urinary incontinence after prenotification.Adverse events & symptoms: recurrent urinary tract infections (utis).Muscle pain in legs & lower back, especially at night or when climbing stairs.Urinary retention and pronounced urgency-type incontinence (no longer stress incontinence).Physical complaints: leg & abdominal muscle/joint pain, fatigue, frequent urination, urine retention, strong urine odor, nausea, dizziness, and loss of balance.Incontinence episodes every 3¿4 hours due to urgency, severely impacting daily and professional life.
Additional Manufacturer Narrative
Additional information: h6,h11.Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation."a manufacturing record evaluation was performed for the finished device lot number 3939733 (product code 810081l), were found.Nr reviewer has reviewed the nr file and has concluded, based on the information available in the nr file, that nr-(b)(4) and nr-(b)(4) are not related to the reported complaint condition or identified malfunction.Expiration date : 31.Jul.2022 manufacturing date : 27.Aug.2021" 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 c26-2980.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Common Device Name: TVT-CAL-OBTURATOR
• 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: 24083032
• Report Number: 3003990090-2026-02005
• Device Sequence Number: 5879086
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/27/2026

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: 810081L
• Device Lot Number: 3939733
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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