MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number CAL-DS01B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)

Event Date 10/10/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 310708452
• Report Number: 3003990090-2023-01552
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: White