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 Code	Bacterial Infection (1735)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per 522/cec : (b)(6) 2022 - desara blue implanted, cystoscopy confirmed normal/no surgical injury.Subject discharged (b)(6) 2022 without issue.Bacterial vaginosis reported wih an onset date of aug 2, 2023.Event was considered ongoing, though noted to be recovering/resolving.Event is being treatdwith flagyl 500md bid.Patient follow-up confirmed the ae is not attributed to mesh erosion.

• 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: 18369389
• Report Number: 3003990090-2023-01572
• Device Sequence Number: 7580398
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/18/2023

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?: No
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: CAL-DS01B
• Device Lot Number: L03018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• 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: 57 YR
• Patient Sex: Female
• Patient Race: White