MAUDE Adverse Event Report: CALDERA MEDICAL INC. TVT EXACT RETROPUBIC SYSTEM; TVT-CAL-EXACT

Model Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Prolapse (2475)
Date of Event	08/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a gynecological surgery on (b)(6) 2015 and tvt-e was implanted.It was reported that patient underwent removal surgery on (b)(6) 2021.It was reported the patient experienced prolapse and recurrent uti.No additional information was reported.
Additional Manufacturer Narrative
The investigation is ongoing.The internal complaint's number is (b)(4).
Additional Manufacturer Narrative
Additional information a1, d4, e1, h4, h6.H11.Correction: g1."a manufacturing record evaluation was performed for the finished lot number 3864449 (product code tvtrl), and no non-conformances/manufacturing irregularities were identified.Expiration date: 31.Jul.2016 manufacturing date : 24.Aug.2015"."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 internal complaint number is (b)(4).

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA
• 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
• MDR Report Key: 24190712
• Report Number: 3003990090-2026-02019
• Device Sequence Number: 7894233
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 07/31/2016
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3864449
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2015
• 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
• Patient Sex: Female