MAUDE Adverse Event Report: CALDERA MEDICAL TVT-CAL-OBTURATOR; TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

Model Number	"TVT-CAL-OBTURATOR"
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pelvic Pain (4865)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.
Event or Problem Description
Wcq received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and tvt-o was implanted.It was reported that the patient experienced chronic pelvic and groin pain, bladder dysfunction, recurrent urinary tract infections, vaginal discharge, and sexual dysfunction.No additional information was reported.

• Brand Name: TVT-CAL-OBTURATOR
• Common Device Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• 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: 23039879
• Report Number: 3003990090-2025-01613
• Device Sequence Number: 10082028
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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
• Device Model Number: "TVT-CAL-OBTURATOR"
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown