MAUDE Adverse Event Report: CALDERA MEDICAL DESARA ONE

Model Number CAL-DS2111

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

Patient Problem Urinary Tract Infection (2120)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Per (b)(4) study, patient reported; uti from (b)(6) 2022.Event was treated with nitrofurantoin and is considered resolved.Cec adjudicated event was not related to device/product.Uti (b)(6) 2022.Event was treated with nitrofurantoin and is considered resolved.Cec adjudicated event was not related to device/product.

• Brand Name: DESARA ONE
• Type of Device: DESARA ONE
• 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: 16486488
• MDR Text Key: 310708943
• Report Number: 3003990090-2023-01559
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00890594000964
• UDI-Public: 00890594000964
• 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: 03/05/2023

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 Operator: Health Professional
• Device Expiration Date: 12/19/2023
• Device Model Number: CAL-DS2111
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N06014
• 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
• Date Device Manufactured: 06/29/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White