MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number	CAL-DS2113
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per 522 study, patient was unable to void post-surgery on (b)(6) 2022 and was sent home with a catheter that was used for 5 days post-op.Patient returned 5 days after procedure and it was confirmed that the event was resolved at that time.Cec adjudicated that the event was possibly related to device/product and/or procedure.Post-op urinary retention was reported on (b)(6), 2022.Subject self-catherterized during this time and event is considered resolved.Cec adjudicated event is possibly related to device/product 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 (Section G): 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: 16486524
• Report Number: 3003990090-2023-01555
• Device Sequence Number: 6919481
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/05/2023

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: 01/22/2023
• Device Model Number: CAL-DS2113
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: M07040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian