MAUDE Adverse Event Report: CALDERA MEDICAL Desara One; DESARA ONE SIS

Model Number	CAL-DS2113
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Perforation (2001); Uterine Perforation (2121)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022: desara one sis implanted.Cystoscopy confirmed mesh in bladder.Repair of urethra and placement of sling was required (revision/resurgery) to address perforation of urethra (injury by surgeon not with trocar) at time of sling implant procedure.Symptoms of mesh exposure confirmed to be resolved at time of revision.Dates of urethra perforation (right lateral): on (b)(6) 2022 ae was determined by investigator to be: moderate, not related to desara one device, definitely to sling implant procedure, not related to concomitant procedure.

• Brand Name: Desara One
• Common Device Name: DESARA ONE SIS
• 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: 15745359
• Report Number: 3003990090-2022-01543
• Device Sequence Number: 5402609
• Product Code: PAH
• UDI-Device Identifier: 00890594000971
• UDI-Public: 00890594000971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: CAL-DS2113
• Device Catalogue Number: CAL-DS2113
• Device Lot Number: N04028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White