MAUDE Adverse Event Report: CALDERA MEDICAL INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; TVT-CAL-EXACT

Lot Number	5000027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical trial patient (b)(6) that patient (b)(6) experienced post-operative urinary retention.The relationship to the study device is considered unlikely.On april 21, 2026, it was noted that a surgical intervention was performed on (b)(6) 2026.
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported as soon as they are available.The internal complaint's manufacture number is (b)(4).
Additional Manufacturer Narrative
Additional information: h6, h11."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 device lot number 5000027 (product code tvtrl), and (b)(4) was found.Nr reviewer has reviewed the nr file and has concluded, based on the information available in the nr file, that (b)(4) is not related to the reported complaint condition or identified malfunction.Expiration date: 31.Aug.2026.Manufacturing date: 04.Sep.2025." as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.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 internal complaint number is (b)(4).

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr,; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL- ETHICON SARL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• MDR Report Key: 24942299
• Report Number: 3003990090-2026-02058
• Device Sequence Number: 8926833
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/14/2026

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 Lot Number: 5000027
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Patient Age: 51 YR
• Patient Sex: Female