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 Urinary Retention (2119)

Event Date 09/12/2023

Event Type  Injury  

Event Description

Per 522/cec: urinary retention requiring catheterization was reported.Subject required catheter for 7 days following surgery.(sept 12-18, 2023) event is considered resolved.Per 522/cec: sept 12, 2023 desara one was implanted without injury.Subject was discharged same day without voiding and with an indwelling catheter.Cec adjudicated the ae is possibly related to the device, sling procedure, and/or concomitant procedure.Based on the information provided, it is unclear whether the ae is due to the product/device, surgical technique, or patient surgical history/anatomy.

• 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: 18369388
• MDR Text Key: 331047559
• Report Number: 3003990090-2023-01575
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00890594000957
• UDI-Public: 00890594000957
• 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: 12/20/2023

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
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Race: White