MAUDE Adverse Event Report: CALDERA MEDICAL TVT-CAL-OBTURATOR; GYNECARE TVT OBTURATOR W LASR

Catalog Number	TVT-CAL-OBTURATOR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of design history file showed no anomalies.Product met the manufacturing specifications.Based on limited information that is provided, the complaint could not be confirmed.As related to the product deficiency.
Event or Problem Description
Upon awakening of very strong pain in the eldest right leg, impossibility of walking, lifting the foot, dressing.Date#1 after tot strip application extremely severe pain of cruralgae/scialgia type.Scanner, mri.Persistent severe disabling pain.Removal of the tot strip on date#2 by dr.(b)(6).

• Brand Name: TVT-CAL-OBTURATOR
• Common Device Name: GYNECARE TVT OBTURATOR W LASR
• 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: 22835370
• Report Number: 3003990090-2025-01606
• Device Sequence Number: 15912203
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/18/2025

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?: No
• Device Catalogue Number: TVT-CAL-OBTURATOR
• Device Lot Number: 3944938
• 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: 08/18/2025
• 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: Female