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

Model Number	810081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Prolapse (2475)
Date of Event	12/10/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent hernia repair surgery on (b)(6) 2005, and gynecare tvt-e was implanted.It was reported that the patient experienced pain and protrusion, rectocele, cystocele, erosion, and extrusion.It was reported that the patient underwent revision surgery on (b)(6) 2006 and another removal surgery of mesh on (b)(6) 2012.No additional information was reported.
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported.The manufacturing number is c25-2886.
Additional Manufacturer Narrative
Correction: b1, h1, addtional information: d5, e1, h6, h11.H11: product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.The manufacturing number is (b)(4).

• Brand Name: GYNECARE TVT OBTURATOR
• Common Device Name: TVT-CAL-OBTURATOR
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• 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, CA 91361
• MDR Report Key: 23407545
• Report Number: 3003990090-2025-01688
• Device Sequence Number: 8806989
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 810081
• Device Lot Number: 297961
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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