MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE

Catalog Number	CAL-DS01B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Intermenstrual Bleeding (2665); Genital Bleeding (4507)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Desara blue was implanted on (b)(6)2022, and on (b)(6)2022, patient reported postcoital bleeding and deep pain with intercourse.Event is ongoing and has been treated with (non-specific) medical intervention.Subject is part of 522 study, and cec has adjudicated ae is not related to the device and is possibly related to the procedure and/or concomitant procedure.

• Brand Name: DESARA BLUE
• Common Device Name: DESARA BLUE
• 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: 16964366
• Report Number: 3003990090-2023-01564
• Device Sequence Number: 5391990
• Product Code: OTN
• UDI-Device Identifier: 00890594000667
• UDI-Public: 00890594000667
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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?: No
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: CAL-DS01B
• Device Lot Number: K08015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White