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 Problem Dysuria (2684)

Event Date 08/01/2022

Event Type  Injury  

Event Description

As a result of (b)(4) study, patient reported; dysuria on (b)(6) 2022, treated with macrobid and is considered resolved.Cec adjudicated not related to device/product.Menopausal vaginal dryness on (b)(6) 2022, cec adjudicated not related to device/product.Dribbling on (b)(6) 2022, cec adjudicated possibly related to device/product, no further information provided.

• 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: 16487049
• MDR Text Key: 310714415
• Report Number: 3003990090-2023-01551
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• 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

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: CAL-DS01B
• Device Lot Number: L03018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Race: White