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 Codes	Hypoxia (1918); Respiratory Failure (2484)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per 522 / cec: on (b)(6) 2023, desara one implanted with no evidence of injury.Subject was discharged on the following day without issue.Per 522 / cec: acute respiratory failure with hypoxia was reported from on (b)(6) 2023.The is considered an sae due to hospitalization.Concomitant medications have not yet been recorded in edc, though records were requested for review.Cec adjudicated the ae is severe, not related to desara one device, sling implant procedure or concomitant procedure.Most likely anesthetic-related.

• 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: 18369386
• Report Number: 3003990090-2023-01576
• Device Sequence Number: 12657519
• 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
• 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): 12/20/2023

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 Expiration Date: 09/08/2024
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: P02032
• 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: 03/08/2023
• 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: Life Threatening; Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White