MAUDE Adverse Event Report: CALDERA MEDICAL, INC VERTESSA LITE Y-MESH; SURGICAL MESH

Model Number	CAL-DS2111
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Retention (2119)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information has been reported.The device(s) have not been returned.Device history records were reviewed and device met all acceptance criteria.The event is a known adverse reaction as listed in the device labeling.Based on the complaint information provided, it is inconclusive if the event is related to the device, surgical approach, surgeon experience, and/or patient anatomy.This report is filed pursuant to 21 cfr 803 and all information contained within this report is subject to the details provided by the reporter.Any subsequent information will be provided in a follow-up report.
Event or Problem Description
Surgeon reported patients presented with retention post-surgery.Surgeon intervened with sling revisions and reports that patients are doing well after sling revisions.

• Brand Name: VERTESSA LITE Y-MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): CALDERA MEDICAL, INC; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL, INC; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer Contact: vicki gail ; 4360 park terrace drive; suite 140; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 20854711
• Report Number: 3003990090-2024-01579
• Device Sequence Number: 8801203
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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 Model Number: CAL-DS2111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 12/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female