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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the lot number associated with the reported event was not identified.Without a lot number, a review of device history records or production-specific data could not be conducted, thereby limiting the ability to perform a thorough root cause investigation.Based on the limited information provided, the reported product complaint could not be confirmed.Based on the information available, no further action is required at this time.
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) 2010 and tvt obturator was implanted.It was reported that the patient experienced stress urinary incontinence, painful intercourse, rectal prolapse, infection, urinary and bowel issues, erosion, uterine prolapse, cystocele, rectocele, abdominal pain, bleeding, burning, discharge, foul smell and discomfort.No additional information was reported.".

• Brand Name: "TVT-CAL-OBTURATOR"
• Common Device Name: "GYNECARE TVT OBTURATOR"
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr. suite140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL SARL-NEUCHATEL; puits-godet 20; neuchatel 2000, ; SZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village 91361
• MDR Report Key: 23292865
• Report Number: 3003990090-2025-01629
• Device Sequence Number: 10028019
• 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: 2010
• 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): 10/14/2025

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
• 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: 10/15/2025
• 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
• Patient Sex: Unknown