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

Model Number CAL-DS01BTV30

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

Patient Problem Urinary Retention (2119)

Event Date 03/21/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 315585219
• Report Number: 3003990090-2023-01561
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 05/19/2023
• 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): Hospitalization; Other
• Patient Sex: Female