MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	810081
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent hernia repair surgery on an unknown date in 2006 and and a mesh was implanted.It was reported that patient underwent partial removal surgery in 2010 and 2016.It was reported that patient experienced pain and bleeding.No additional information was reported.
Additional Manufacturer Narrative
Date sent to the fda: 10/23/2025.D4: the device catalog number is unknown; therefore, udi is unavailable.(b)(4) submitted for adverse event which occurred on --/--/2010.(b)(4) submitted for adverse event which occurred on --/--/2016.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Date sent to the fda: 4/21/2026.Additional information: d4 (catalog, lot #, primary udi #) corrected information: d1, d2a, d2b, d3, d6a, g1 additional b5 narrative: it was reported that patient underwent a gynecological procedure on (b)(6) 2006 and tvt-o was implanted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Date sent to the fda: 5/13/2026.Additional information: d4 (expiration), h4 corrected information: d4 (primary udi #) a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GYNECARE TVT
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace drive; westlake village CA 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 23368707
• Report Number: 2210968-2025-12175
• Device Sequence Number: 13249472
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: (01)10705031000346(17)060331(10)1301581
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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 Expiration Date: 03/31/2006
• Device Catalogue Number: 810081
• Device Lot Number: 1301581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 03/30/2026; 05/13/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 04/21/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2006
• 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