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	Urinary Retention (2119)
Date of Event	06/01/2023
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.Voiding was not possible, and subject was discharged with instructions to self-catheterize (which she did for 8 days).Urinary retention requiring catheterization reported from june 1 - oct.10, 2023.Event was initially treated with urologs and self-catheterizing, then subject underwent revision / resurgery, "sling revision for voiding dysfunction or retention; cut sling" on (b)(6) 2023.Event is now resolved.

• 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: 18369385
• Report Number: 3003990090-2023-01574
• Device Sequence Number: 7580397
• 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: 04/20/2024
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N10025
• 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
• Date Device Manufactured: 10/20/2022
• 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: Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: White