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

Model Number	CAL-DS01BTV30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon has 2 cases of retention with desara tvez3.0 with patients unable to void post-op.Exact date of procedure for each patient is unknown.Based on information provided, it is unclear wether the event is related to the product, patient medical history, or surgical technique.

• Brand Name: DESARA TVEZ
• Common Device Name: DESARA TVEZ 3.0
• 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: 16964363
• Report Number: 3003990090-2023-01561
• Device Sequence Number: 20143266
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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 Model 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: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Other
• Patient Sex: Female