MAUDE Adverse Event Report: CALDERA MEDICAL DESARA; DESARA TVEZ 3.0

Catalog Number	CAL-DS01BTV30
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had retention using desara tvez3.0, voiding 0 ml.

• Brand Name: DESARA
• Common Device Name: DESARA TVEZ 3.0
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village 91361
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91361
• MDR Report Key: 17600519
• Report Number: 3003990090-2023-01569
• Device Sequence Number: 17718928
• Product Code: OTN
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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-DS01BTV30
• Device Lot Number: N09064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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
• Patient Sex: Female