MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; TVT-CAL-RETROPUBIC

Catalog Number	810041B
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Dyspareunia (4505)
Date of Event	09/03/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported: for 1 year following implantation of the second strips of tvt, the patient experienced recurrent urinary infections, including 4 episodes of pyelonephritis, after her 2nd delivery; there was follow-up with numerous examinations and antibiotic treatments from 2010 to 2013, followed by a period of calm.Right inguinal fossa pain and dyspareunia have been present since 2016, along with discomfort with walking and sports since 2016.The patient reports recurrent infections, with 15 episodes in 9 months.Evaluation is currently in progress and has visualized one strip in the urethral mucosa, while the other is considered ineffective due to misorientation.
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)(4).

• Brand Name: GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
• 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): 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: 24927282
• Report Number: 3003990090-2026-02059
• Device Sequence Number: 5180347
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 810041B
• Device Lot Number: 1347621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/20/2026
• 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