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

Model Number	810081L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Pelvic Pain (4865)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the device is not returned.Based on the limited information provided, the reported product complaint could not be confirmed.A review of general manufacturing records indicates that all products released during the relevant timeframe were manufactured in accordance with approved procedures and met established specifications during the manufacturing and quality release process.
Event or Problem Description
"pain ++ inside left thigh with almost impossible to walk after surgery.At the echo the strip passes into the adductor.1 th surgical resumption for partial removal date 1.Pain in the buttocks indicating conflict with obturators.2th resumed for new partial withdrawal on date 2.Always pains especially left buttock at prolonged sitting but also at the level of the inside of the left thigh and at walking simple moderate pains inside the left thigh rising up in the groin and accentuated in descent or uphill.Very disabling pain.4 months of complete work stoppage and since mid-june resumption of my professional activity in therapeutic half-time.".
Additional Manufacturer Narrative
Additional information: d4, d5, e1, e3, g4, h4 ,h5 , h6, h11.Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished lot number 3944899 (product code 810081l), and no non-conformances / manufacturing irregularities were identified.Expiration date: 31.Aug.2025 manufacturing date : 20.Sep.2024 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing number is (b)(4).

• 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: 23022449
• Report Number: 3003990090-2025-01611
• Device Sequence Number: 9546497
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201686
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 08/31/2025
• Device Model Number: 810081L
• Device Catalogue Number: TVT-CAL-OBTURATOR
• Device Lot Number: 3944899
• 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: 01/30/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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
• Patient Sex: Unknown