MAUDE Adverse Event Report: CALDERA MEDICAL DESARA; DESARA TVEZ 2.7

Lot Number P01005

Device Problem Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Desara tvez 2.7 mesh was pulled out of the sleeve while loading the implant onto the securement arms.

• Brand Name: DESARA
• Type of Device: DESARA TVEZ 2.7
• 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: 17608414
• MDR Text Key: 321810355
• Report Number: 3003990090-2023-01570
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00089059400193
• UDI-Public: 0089059400193
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: P01005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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): Hospitalization
• Patient Sex: Female