MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; TVT-CAL-RETROPUBIC

Model Number	810041B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Prolapse (2475); Urinary Incontinence (4572)
Date of Event	11/11/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
The wcq received an email from the ethicon risk manager team reporting the following: the patient underwent a gynecological surgical procedure on (b)(6) 2005, during which a tvt (tension-free vaginal tape) was implanted.The patient subsequently had revision surgery on (b)(6) 2015.It was reported that the patient experienced pain, an endometrial polyp, irregular bleeding, a cystocele, and stress urinary incontinence.No additional information was provided.
Additional Manufacturer Narrative
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 W/PRLNE BLUE MESH 1 EACH
• Common Device Name: TVT-CAL-RETROPUBIC
• 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: 23369245
• Report Number: 3003990090-2025-01659
• Device Sequence Number: 10089659
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: 810041B
• Device Lot Number: 1309422
• 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: 08/18/2025
• Initial Report FDA Received Date: 10/23/2025
• 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; Other
• Patient Sex: Female