MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number	CAL-DS2111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a desara one sling implanted on (b)(6) 2023.Patient expierenced retention issues post operatively.Patient went back to the hospital where the surgeon removed the sling.Sling was not returned to manufacturer for evaluation.Based on the information provided, it is unclear whether the ae is related to product/device, patient anatomy, medical history, or surgical technique.

• Brand Name: DESARA ONE
• Common Device Name: DESARA ONE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91361
• MDR Report Key: 16920035
• Report Number: 3003990090-2023-01560
• Device Sequence Number: 6910803
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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: CAL-DS2111
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N11037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Female