MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number	CAL-DS01B
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 3003990090-2022-01536
• Device Sequence Number: 20140255
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female