MAUDE Adverse Event Report: CALDERA MEDICAL INC. TVT EXACT RETROPUBIC SYSTEM; TVT-CAL-EXACT

Catalog Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Constipation (3274)
Date of Event	03/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent laparoscopic promontofixation for grade 3/4 cystocele on (b)(6) 2025 with tht bioscience pro swing ps4 monofilament polypropylene mesh, ref (b)(4), lot 24070428.Post-op recovery was uneventful with normal voiding at discharge 04/feb/2025.Following surgery, patient developed unmasked stress urinary incontinence.On 21/mar/2025 she underwent retropubic tvt procedure with gynecare tvt exact sling, ethicon tvtrl, lot 3944960.Intra-operative cystoscopy confirmed correct placement; patient discharged (b)(6) 2025 with normal voiding and no post-void residual.Follow-up (b)(6) 2025: uro-scanner normal.Patient reported persistent mixed constipation and right ilio-inguinal neuropathic pain treated with lumbar tens.(b)(6) 2026 urology note: continued pain, constipation, and significant quality-of-life impact.Patient states she "no longer goes out" and is "suffering and depressed following treatment for pain." no device exposure, erosion, or malfunction documented to date.Patient reports ongoing chronic pain and depression following the two implant procedures.
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported as soon as they are available.The internal complaint's manufacture number is (b)(6).

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr,; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL- ETHICON SARL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• MDR Report Key: 25048494
• Report Number: 3003990090-2026-02068
• Device Sequence Number: 10457508
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: TVTRL
• Device Lot Number: 3944960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/30/2026
• 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