MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number CAL-DS01B

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

"they were doing 02-019 sling placement.She said they had to use two devices because the first device "curled in the sub-urethral area.".

• Brand Name: DESARA BLUE
• Type of Device: DESARA BLUE
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village 91361 5696
• Manufacturer (Section G): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361 5696
• Manufacturer Contact: ryan troncoso
• MDR Report Key: 15135775
• MDR Text Key: 304695081
• Report Number: 3003990090-2022-01536
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CAL-DS01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female