MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number	CAL-DS01B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Dysuria (2684)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of (b)(4) study, patient reported; uti on (b)(6) 2022, event treated with azo (prn, macrobid, and levaquin, cec adjudicated not related to product.Worsened prolaspe on (b)(6) 2022 and is considered ongoing.Cec adjudicated not related to product.Dysuria on december (b)(6) 2022, event treated with macrobid.Cec requested more information.

• Brand Name: DESARA BLUE
• Common Device Name: DESARA BLUE
• 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: 16486538
• Report Number: 3003990090-2023-01549
• Device Sequence Number: 6787060
• Product Code: OTN
• UDI-Device Identifier: 00890594000667
• UDI-Public: 00890594000667
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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-DS01B
• Device Lot Number: M10009
• 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 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: 54 YR
• Patient Sex: Female