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); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per (b)(4) study, it was reported; urinary retention requiring catheterization on (b)(6) 2022.Event treated by subject self-catheterizing, and pyridium and bactrim.Event is considered resolved.Cec adjudicated event possibly related to device/product and/or procedure.Urinary tract infection (b)(6) 2022, event treated with cipro and is considered resolved.Cec adjudicated not related to device/product.Worsening urgency on (b)(6) 2022.Event has been treated with oxybutynin cr and myrbetriq.Cec adjudicated event is possibly related to device/product.Dysuria on (b)(6) 2022, required medical intervention and is resolving.Cec adjudicated event is possibly related to device/product.

• Brand Name: DESARA BLUE
• Common Device Name: DESARA BLUE
• 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: 16486487
• Report Number: 3003990090-2023-01552
• Device Sequence Number: 5912274
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• 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
• 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: N04041
• Was Device Available for Evaluation?: No
• 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; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: White