MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number CAL-DS01B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 11/08/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 310708714
• Report Number: 3003990090-2023-01549
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000667
• UDI-Public: 00890594000667
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female