MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Catalog Number CAL-DS2113

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspareunia (4505)

Event Date 05/31/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 331047086
• Report Number: 3003990090-2023-01573
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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 Catalogue Number: CAL-DS2113
• Device Lot Number: N12011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Race: White