MAUDE Adverse Event Report: CALDERA MEDICAL DESARA; DESARA CLEAR

Catalog Number CAL-DS01

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Reported case of erosion with desara clear product.Implanted on (b)(6) 2022.Unclear whether the event is due to product device, patient medical history, or surgical technique.

• Brand Name: DESARA
• Type of Device: DESARA CLEAR
• 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: 18103826
• MDR Text Key: 327754432
• Report Number: 3003990090-2023-01567
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000889
• UDI-Public: 00890594000889
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2023

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?: Yes
• Device Catalogue Number: CAL-DS01
• Device Lot Number: N07055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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 Sex: Female