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

Model Number	810041BL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the lot number associated with the reported event was not identified.Without a lot number, a review of device history records or production-specific data could not be conducted, thereby limiting the ability to perform a thorough root cause investigation.Based on the limited information provided, the reported product complaint could not be confirmed.
Event or Problem Description
Defective healing of the urethral incision resulted in vaginal exposure of the prosthesis at the delivery scar.This required surgery in the operating room for scar recovery, in ambulatory surgery, with in some cases partial excision of the strip.
Additional Manufacturer Narrative
Additional information: a3, b2, d4, d5, d6a, e1, e3, g4, h4, h5, h6, h11.Investigation results: an analysis of the product could not be conducted because a physical sample was not received for evaluation.A review of the manufacturing records for the finished lot number 3944918 (product code 810041bl) was performed, and no non-conformances or manufacturing irregularities were identified.The expiration date for this product is october 31, 2027, and the manufacturing date is november 6, 2024.According to our company's quality system, all devices are manufactured, inspected, and distributed in accordance with approved specifications.Based on the available information, there is no evidence that a design or manufacturing issue has contributed to the reported complaint.Therefore, it has been concluded that no corrective or preventive action is required at this time.We will continue to monitor additional complaint information for potential safety signals through complaint trending as part of our post-market surveillance.If a product sample is received later, we will update the investigation as necessary.The manufacturing number is (b)(4).

• Brand Name: TVT-CAL-RETROPUBIC
• Common Device Name: GYNECARE TVT RETROPUBIC DEVICE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): ETHICAN SARL-NEUCHATEL; puits-godet 20; neuchatel 2000, ; WZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr.; suite 140; westlake village, CA 91361
• MDR Report Key: 23020540
• Report Number: 3003990090-2025-01610
• Device Sequence Number: 13154986
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/09/2025

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: 3944918
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: Other; Required Intervention
• Patient Sex: Female