MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Catalog Number	CAL-DS2113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspareunia (4505)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per 522/cec: (b)(6) 2023 - desara one implanted; cystoscopy confirmed no surgical injury.Subject discharged on the same day without issue.Subject reported de novo dyspareunia beginning may 31, 2023.Event is considered ongoing.Treatment for this event included revision / resurgery on (b)(6) 2023.Sling was removed and a new sling placed.Cec adjudicated the ae is possibly related to device and/or sling procedure.

• 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: 18369387
• Report Number: 3003990090-2023-01573
• Device Sequence Number: 18037326
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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 Expiration Date: 06/08/2024
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N12011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Race: White